| 1. Bosch J, Berzigotti A, Garcia-Pagan JC, Abraldes JG. The management of portal hypertension: rational basis, available treatments and future options. J Hepatol. 2008;48 Suppl 1:S68-92. |
Review/Other-Tx |
N/A |
To review the rationale for the management of patients with cirrhosis and portal hypertension, the current recommendations for the prevention and treatment of variceal bleeding, and outlines the unsolved issues and the perspectives for the future opened by new research developments. |
No results stated in abstract. |
4 |
| 2. Bari K, Garcia-Tsao G. Treatment of portal hypertension. World J Gastroenterol. 2012;18(11):1166-1175. |
Review/Other-Tx |
N/A |
To discuss the standard of care for acute variceal hemorrhage, consisting of vasoactive drugs, endoscopic band ligation and antibiotics prophylaxis. |
No results stated in abstract. |
4 |
| 3. Kim CY, Pinchot JW, Ahmed O, et al. ACR Appropriateness Criteria® Radiologic Management of Gastric Varices. J Am Coll Radiol 2020;17:S239-S54. |
Review/Other-Tx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for radiologic management of gastric varices. |
No results stated in abstract. |
4 |
| 4. Schmidt ML, Barritt AS, Orman ES, Hayashi PH. Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Gastroenterology. 2015;148(5):967-977 e962. |
Review/Other-Tx |
781,515 patients |
To investigate changes in inpatient outcomes and associated features over time. |
The mortality of patients with and without cirrhosis, and patients with CHF, decreased over time. The absolute decrease was significantly greater for patients with cirrhosis (from 9.1% to 5.4%) than for patients without cirrhosis (from 2.6% to 2.1%) or patients with CHF (from 2.5% to 1.4%) (P < .01). However, relative decreases were similar for patients with cirrhosis (41%) and patients with CHF (44%). For patients with cirrhosis, the independent mortality risk ratio decreased steadily to 0.50 by 2010 (95% confidence interval, 0.48-0.52), despite patients' increasing age and comorbidities. Hepatorenal syndrome, hepatocellular carcinoma, variceal bleeding, and spontaneous bacterial peritonitis were associated with a higher mortality rate, but the independent mortality risks for each decreased steadily. Sepsis was associated strongly with increased mortality, and the risk increased over time. |
4 |
| 5. Gines P, Quintero E, Arroyo V, et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987;7(1):122-128. |
Review/Other-Tx |
293 patients |
To investigate the natural history of compensated cirrhosis, 293 consecutive patients without previous major complications (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) were studied in terms of morbidity (probability of developing decompensated cirrhosis during follow-up) and survival. |
Ten years after diagnosis, the probability of developing decompensated cirrhosis and the survival probability rate were 58 and 47%, respectively. A multivariate survival analysis (Cox's regression model) using clinical, biochemical and histological data obtained at diagnosis disclosed seven factors that predicted prognosis: serum bilirubin; serum gamma-globulin concentration; hepatic stigmata; prothrombin time; sex; age, and alkaline phosphatase. |
4 |
| 6. D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol. 2006;44(1):217-231. |
Review/Other-Tx |
118 patients |
To develop a Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies |
No results stated in abstract. |
4 |
| 7. Planas R, Montoliu S, Balleste B, et al. Natural history of patients hospitalized for management of cirrhotic ascites. Clin Gastroenterol Hepatol. 2006;4(11):1385-1394. |
Review/Other-Tx |
263 patients |
To define the natural history of cirrhotic ascites and to identify prognostic factors for dilutional hyponatremia (DH), RA, HRS, and survival. |
During follow-up 74 (28.1%) patients developed DH, 30 (11.4%) RA (diuretic-resistant in 2 cases and diuretic-intractable because of the development of diuretic-induced complications in 28 cases), and 20 (7.6%) HRS (type 1, 7; type 2, 13). The 5-year probability of DH, RA, and HRS development was 37.1%, 11.4%, and 11.4%, respectively. The probability of survival at 1 and 5 years was 85% and 56.5%, respectively. The independent predictors for survival were baseline age, baseline Child-Pugh score, and DH development. The 1-year probability of survival after developing DH, RA, and type 2 HRS was 25.6%, 31.6%, and 38.5%, respectively. In contrast, the mean survival was only 7 +/- 2 days in those patients developing type 1 HRS. |
4 |
| 8. D'Amico G, Luca A. Natural history. Clinical-haemodynamic correlations. Prediction of the risk of bleeding. Baillieres Clin Gastroenterol. 1997;11(2):243-256. |
Review/Other-Tx |
N/A |
To demonstrate that portal hypertension dominates the clinical course of cirrhosis by promoting the development of oesophageal varices and ascites. |
Mortality per bleeding episode is 30-50%. Among survivors 60% will rebleed and 30% will die in the following year. The risk of rebleeding decreases in patients with spontaneous or treatment induced reduction of portal pressure gradient or variceal pressure. Ascites develops in almost all patients along the course of the disease. Median survival after its appearance is less than 2 years. Less than 5% of cirrhotic patients die without ascites or without a previous bleeding. |
4 |
| 9. Runyon BA. Refractory ascites. Semin Liver Dis. 1993;13(4):343-351. |
Review/Other-Tx |
N/A |
To determine whether portal hypertension is present (SAAG 1.1 g/dl or higher) or not (SAAG less than 1.1 gm/dl) (Table 1). |
The 10% of patients with cirrhosis whose ascites is refractory to routine medical treatment must be offered alternative therapy. |
4 |
| 10. Russo MW, Sood A, Jacobson IM, Brown RS, Jr. Transjugular intrahepatic portosystemic shunt for refractory ascites: an analysis of the literature on efficacy, morbidity, and mortality. Am J Gastroenterol. 2003;98(11):2521-2527. |
Review/Other-Tx |
N/A |
To determine from the literature the efficacy, morbidity, and mortality associated with TIPS for refractory ascites. |
Of 25 studies identified, 16 were included in the analysis. The pooled estimate for complete response at 6 months was 45% and for any response (complete and partial) was 63%. Pooled 6-month mortality after TIPS was 36%. Risk factors for mortality included renal insufficiency (serum creatinine >1.5 mg/dl), hyperbilirubinemia (total bilirubin >3 mg/dl), advanced age (>60 yr), and poor response to TIPS. The pooled rate of new or worsening encephalopathy after TIPS was 32%. In most cases, encephalopathy was managed medically or by reduction in shunt size; however, refractory cases were associated with 100% mortality in most studies. Studies reporting the effect of TIPS on kidney function showed improvement in creatinine clearance and urinary sodium excretion. |
4 |
| 11. Gines P, Guevara M, Arroyo V, Rodes J. Hepatorenal syndrome. Lancet 2003;362:1819-27. |
Review/Other-Dx |
N/A |
To discuss therapies that lower the frequency of Hepatorenal Syndrome (HRS) in clinical practice such as vasoconstrictor drugs and the transjuglar intrahepatic portosystemic shunt , which are effective in improving renal function. |
N/A |
4 |
| 12. Gines P, Schrier RW. Renal failure in cirrhosis. N Engl J Med 2009;361:1279-90. |
Review/Other-Dx |
N/A |
To discuss the prevention and management of renal failure in cirrhosis. |
N/A |
4 |
| 13. Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007;56(9):1310-1318. |
Review/Other-Tx |
N/A |
To discuss the diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. |
No results stated in abstract. |
4 |
| 14. Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Postgrad Med J. 2008;84(998):662-670. |
Review/Other-Tx |
N/A |
To report the scientific rationale behind the new definitions and recommendations of an international workshop included four issues: (1) evidence-based HRS pathogenesis; (2) treatment of HRS using vasoconstrictors; (3) other HRS treatments using transjugular intrahepatic portosystemic stent-shunt (TIPS) and extracorporeal albumin dialysis (ECAD); and (4) new definitions and diagnostic criteria for HRS and recommendations for its treatment. |
No results stated in abstract. |
4 |
| 15. Abraldes JG, Villanueva C, Banares R, et al. Hepatic venous pressure gradient and prognosis in patients with acute variceal bleeding treated with pharmacologic and endoscopic therapy. J Hepatol. 2008;48(2):229-236. |
Review/Other-Tx |
117 patients |
To evaluate the performance of early HVPG measurement as a predictor of treatment failure in patients with acute variceal bleeding managed with the current standard treatment and whether clinical variables might be of similar predictive accuracy. |
Eighteen patients (15%) had 5-day failure. Multivariate analysis identified three variables independently associated with 5-day failure: HVPG 20, systolic blood pressure at admission <100 mmHg and non-alcoholic cause of cirrhosis. The discriminative capacity of this model was good (c statistic: 0.79). When only clinical variables were included in the analysis, Child-Pugh class, systolic blood pressure at admission and etiology were the independent predictors. This model had also a good discriminative ability (c statistic: 0.80). |
4 |
| 16. Bosch J, Groszmann RJ, Shah VH. Evolution in the understanding of the pathophysiological basis of portal hypertension: How changes in paradigm are leading to successful new treatments. J Hepatol. 2015;62(1 Suppl):S121-130. |
Review/Other-Tx |
N/A |
To advocate further refinement in the knowledge of the molecular mechanisms involved in the regulation of both the splanchnic and hepatic circulation, that has led to the emergence of new treatments, which are based on evidence that show not only structural but also vasoactive components increase the hepatic vascular resistance, as well as angiogenesis. |
No results stated in abstract. |
4 |
| 17. Silva-Junior G, Baiges A, Turon F, et al. The prognostic value of hepatic venous pressure gradient in patients with cirrhosis is highly dependent on the accuracy of the technique. Hepatology. 2015;62(5):1584-1592. |
Review/Other-Tx |
380 patients |
To establish which gradient better correlates with orthotopic liver transplantation (OLT)-free survival. |
The main cause of cirrhosis was hepatitis C (53%), and the mean Child-Pugh score and Model for End-Stage Liver Disease (MELD) score was 7 and 12, respectively. Mean followup was 43 months with only 3 patients lost to followup. One hundred fifty-one (40%) patients were transplanted (n = 40) or died (n = 111) during follow-up. OLT-free survival rates at 1, 3, and 5 years were 86.5%, 70%, and 59.5%, respectively (Fig. 3A). HVPG-Free was significantly lower than HVPG-IVC (16 6 5 mm Hg for HVPG-Free and 17 6 5.5 mm Hg for HVPGIVC; P < 0.001). |
4 |
| 18. D'Amico G, Garcia-Pagan JC, Luca A, Bosch J. Hepatic vein pressure gradient reduction and prevention of variceal bleeding in cirrhosis: a systematic review. Gastroenterology. 2006;131(5):1611-1624. |
Review/Other-Tx |
N/A |
To perform a systematic review of available studies from the Cochrane Library and MEDLINE. |
Twelve studies were identified including 943 patients. Pooled odds ratios for bleeding for the 3 hemodynamic targets were, respectively, 0.21 (95% CI: 0.10-0.45; P = .0001), 0.25 (95% CI: 0.11-0.56; P = .001), and 0.17 (95% CI: 0.09-0.33; P = .001). A significant heterogeneity was found for the 2 last estimates, and meta-regression analysis showed that this was caused by an exceedingly long interval between HVPG measurements in 1 study. After exclusion of that study, heterogeneity disappeared, and the pooled odds ratios were, respectively, 0.19 (95% CI: 0.11-0.34; P = .0001) and 0.14 (95% CI: 0.09-0.21; P = .0001). The beneficial effect of HVPG reduction for first bleeding was similar to that for recurrent bleeding. Mortality was significantly reduced for HVPG reduction by >/=20% or to </=12 mm Hg (pooled odds ratio, 0.39; 95% CI: 0.19-0.81, P = .012). |
4 |
| 19. Expert Panel on Gastrointestinal Imaging:, Horowitz JM, Kamel IR, et al. ACR Appropriateness Criteria Chronic Liver Disease. J. Am. Coll. Radiol.. 14(11S):S391-S405, 2017 Nov. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for chronic liver disease. |
No results stated in abstract. |
4 |
| 20. Wells M, Chande N, Adams P, et al. Meta-analysis: vasoactive medications for the management of acute variceal bleeds. Aliment Pharmacol Ther. 2012;35(11):1267-1278. |
Meta-analysis |
30 trials; 3111 patients |
To undertake a meta-analysis of the efficacy of vasoactive medications in patients having acute variceal bleeds. |
The search identified 3011 citations, and 30 trials with a total of 3111 patients met eligibility criteria. The use of vasoactive agents was associated with a significantly lower risk of 7-day mortality (RR 0.74; 95% CI 0.57-0.95; P = 0.02; I(2) = 0%; moderate quality of evidence), and a significant improvement in haemostasis (RR 1.21, 95% CI 1.13-1.30; P < 0.001; I(2) = 28%; very low quality of evidence), lower transfusion requirements (pooled mean difference -0.70 units of blood transfused, 95% CI -1.01 to -0.38; P < 0.001; I(2) = 82%; moderate quality of evidence), and a shorter duration of hospitalisation (pooled mean difference -0.71 days; 95% CI -1.23 to -0.19; P = 0.007; I(2) = 0%; low quality of evidence). Studies comparing different vasoactive agents did not show a difference in efficacy, although the quality of evidence was very low. |
M |
| 21. Avgerinos A, Nevens F, Raptis S, Fevery J. Early administration of somatostatin and efficacy of sclerotherapy in acute oesophageal variceal bleeds: the European Acute Bleeding Oesophageal Variceal Episodes (ABOVE) randomised trial. Lancet. 1997;350(9090):1495-1499. |
Experimental-Tx |
205 patients |
To investigate whether early administration of somatostatin would improve the efficacy of sclerotherapy. |
205 patients were enrolled: 101 received somatostatin and 104 received placebo. Treatment failed in 35 somatostatin and 57 placebo recipients (p = 0.004); death or use of rescue therapy occurred in nine and 19 patients, respectively (p = 0.05). The mean quantity of blood products transfused over 120 h (adjusted for baseline haemoglobin) was 2.64 (SD 0.35) units in the somatostatin group versus 3.62 (0.35) units in the placebo group (p = 0.05). At endoscopy, active bleeding from oesophageal varices was less frequent (27 vs 42 patients, p = 0.012) and the sclerotherapy procedure was easier (2.8 vs 4.7 cm, p = 0.0027) in the somatostatin than in the placebo group. |
1 |
| 22. Cales P, Masliah C, Bernard B, et al. Early administration of vapreotide for variceal bleeding in patients with cirrhosis. N Engl J Med. 2001;344(1):23-28. |
Experimental-Tx |
184 patients |
To study the effects of treatment with vapreotide, a somatostatin analogue, begun before endoscopic treatment in 227 patients with cirrhosis who were hospitalized for acute upper gastrointestinal bleeding. |
At the time of endoscopy, active bleeding was evident in 28 of 91 patients in the vapreotide group (31 percent), as compared with 43 of 93 patients in the placebo group (46 percent) (P=0.03). During the five-day infusion, the primary objective--survival and control of bleeding--was achieved in 65 of 98 patients in the vapreotide group (66 percent) as compared with 49 of 98 patients in the placebo group (50 percent) (P=0.02). The patients in the vapreotide group received significantly fewer blood transfusions (2.0+/-2.2 vs. 2.8+/-2.8 units, P=0.04). Overall mortality rates at 42 days were not significantly different in the two groups. |
1 |
| 23. Garcia-Pagan JC, Reverter E, Abraldes JG, Bosch J. Acute variceal bleeding. Semin Respir Crit Care Med. 2012;33(1):46-54. |
Review/Other-Tx |
N/A |
To discuss bleeding from gastroesophageal varices as a frequent complication of cirrhosis. |
A recent trial has shown that placement of TIPS, using covered stents, within 72 hours of admission in patients at high risk of treatment failure (i.e., those Child B with active bleeding or Child C less than 14 points) markedly decreased rebleeding and improved survival. |
4 |
| 24. Levacher S, Letoumelin P, Pateron D, Blaise M, Lapandry C, Pourriat JL. Early administration of terlipressin plus glyceryl trinitrate to control active upper gastrointestinal bleeding in cirrhotic patients. Lancet. 1995;346(8979):865-868. |
Experimental-Tx |
76 patients |
To compare the efficacy of terlipressin combined with glyceryl trinitrate (TER-GTN), administered as early as possible to 76 patients with cirrhosis who had active GIB (84 bleeding episodes). |
In most patients, endoscopy confirmed the rupture of oesophageal varices (75.7%). Bleeding control was significantly better in the TER-GTN group (n = 41) than in the double-placebo group (n = 43) (p = 0.034). Mortality due to bleeding episodes was significantly lower in the TER-GTN group than in the double-placebo group at day 15 (p = 0.035) and at day 42 (p = 0.06). |
1 |
| 25. Villanueva C, Ortiz J, Sabat M, et al. Somatostatin alone or combined with emergency sclerotherapy in the treatment of acute esophageal variceal bleeding: a prospective randomized trial. Hepatology. 1999;30(2):384-389. |
Experimental-Tx |
100 patients |
To assess whether the addition of sclerotherapy improves the efficacy of SMT alone, all patients admitted to our unit with gastrointestinal bleeding and with suspected cirrhosis received a continuous infusion of SMT (250 micrograms/h). |
Therapeutic failure occurred in 21 cases of the SMT group and in 7 cases of the combined-therapy group (P =.002). Failure to control the acute episode occurred in 24% vs. 8% (P =.03) and early rebleeding in 24% vs. 7% (P =.03), respectively. Transfusional requirements were significantly higher in the SMT group, while the incidence of complications was lower (8% vs. 24%; P =.029). In the multivariate analysis, the presence of shock at admission and active bleeding during endoscopy were the variables that better predicted the failure of therapy with SMT alone. Mortality at 6 weeks was similar. |
1 |
| 26. Banares R, Albillos A, Rincon D, et al. Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis. Hepatology. 2002;35(3):609-615. |
Meta-analysis |
8 trials; 939 patients |
To assess whether vasoactive drugs may improve the efficacy of endoscopic therapy (injection sclerosis or band ligation) in the control of AVB and thus increase survival rates. |
Combined treatment improved initial control of bleeding (relative risk [RR], 1.12; 95% confidence interval (CI), 1.02-1.23), and 5-day hemostasis (RR, 1.28; 95% CI, 1.18-1.39), with numbers of patients needed to treat (NNT) of 8 and 5, respectively. The difference in favor of combined treatment remained significant when trials that used drugs other than octreotide or that included a low proportion of alcoholic patients (<40%) or high-risk cirrhotic patients (<35%) were excluded. Mortality was not significantly decreased by combined therapy (RR, 0.73; 95% CI, 0.45-1.18). Severe adverse events were similar in both groups. |
M |
| 27. Wang C, Han J, Xiao L, Jin CE, Li DJ, Yang Z. Efficacy of vasopressin/terlipressin and somatostatin/octreotide for the prevention of early variceal rebleeding after the initial control of bleeding: a systematic review and meta-analysis. Hepatol Int. 2015;9(1):120-129. |
Meta-analysis |
6 studies; 964 patients |
To conduct a meta-analysis to compare the effectiveness of vasopressin/terlipressin and somatostatin/octreotide on variceal re-bleeding within and after 5 days of initial control bleeding. |
Six studies were included in the analysis. Five studies had complete data of re-bleeding rate within 5 days after initial treatment, and the combined odds ratio (OR) of 0.87 [95% confidence interval (CI) 0.51, 1.50] indicated that there was no difference in the re-bleeding rate between patients treated with vasopressin/terlipressin or somatostatin/octreotide. Two studies had complete data of the re-bleeding rate 5 days after initial treatment, and the combined OR of 1.12 (95% CI 0.64, 1.95) indicated there was no difference in the re-bleeding rate between patients who were treated with vasopressin/terlipressin or somatostatin/octreotide. |
M |
| 28. Soares-Weiser K, Brezis M, Tur-Kaspa R, Leibovici L. Antibiotic prophylaxis for cirrhotic patients with gastrointestinal bleeding. Cochrane Database Syst Rev 2002:CD002907. |
Review/Other-Dx |
864 patients (8 trials) |
To evaluate the effects of antibiotic prophylaxis in the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding. |
Eight trials evaluated the effects of antibiotic prophylaxis compared with placebo or no antibiotic prophylaxis in 864 patients. A significant beneficial effect on decreasing mortality (RR 0.73, 95% CI 0.55 to 0.95) and the incidence of bacterial infections (RR 0.40, 95% CI 0.32 to 0.51) was observed. No serious adverse events were reported. The trials showed no significant heterogeneity. Three additional trials evaluated the effects of antibiotics compared with a different regimen of antibiotics in 503 patients. Data could not be combined as each trial used different interventions. None of the examined antibiotic regimens was superior to the control regimen regarding mortality or the incidence of bacterial infections. |
4 |
| 29. Chavez-Tapia NC, Barrientos-Gutierrez T, Tellez-Avila F, et al. Meta-analysis: antibiotic prophylaxis for cirrhotic patients with upper gastrointestinal bleeding - an updated Cochrane review. Aliment Pharmacol Ther 2011;34:509-18. |
Meta-analysis |
1241 patients (12 trials) |
To assess the benefits and harms of antibiotic prophylaxis in cirrhotic patients with gastrointestinal bleeding by performing a systematic review of randomised trials. |
Twelve trials (1241 patients) evaluating antibiotic prophylaxis against placebo or no antibiotic prophylaxis were included. Antibiotic prophylaxis was associated with reduced mortality (RR 0.79, 95% CI 0.63-0.98), mortality from bacterial infections (RR 0.43, 95% CI 0.19-0.97), bacterial infections (RR 0.35, 95% CI 0.26-0.47), rebleeding (RR 0.53, 95% CI 0.38-0.74) and days of hospitalisation (MD -1.91, 95% CI -3.80-0.02). Trials analysing rebleeding rate and hospitalisation length are still scarce, thus, caution should be exerted when interpreting the results. |
Not Assessed |
| 30. de Franchis R. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015;63(3):743-752. |
Review/Other-Tx |
N/A |
No abstract available |
No abstract available |
4 |
| 31. Lo GH, Chen WC, Wang HM, et al. Low-dose terlipressin plus banding ligation versus low-dose terlipressin alone in the prevention of very early rebleeding of oesophageal varices. Gut. 2009;58(9):1275-1280. |
Experimental-Tx |
93 patients |
To assess the efficacy and safety in patients with no active bleeding at endoscopy, receiving banding ligation association with terlipressin to prevent very early rebleeding. |
The terlipressin group was composed of 46 patients and the Combined group was composed of 47 patients. Both groups were comparable in terms of baseline data. Forty-eight-hour haemostasis was achieved in 91% in the Terlipressin group and 98% in the Combined group (p = 0.20). Very early rebleeding within 48-120 h occurred in 7 patients (15%) in the Terlipressin group but not in any patients (0%) in the Combined group (p = 0.006). Treatment failure was 24% in the Terlipressin group and 2% in the Combined group (p = 0.002). Multivariate analysis revealed that treatment (OR 0.081; 95% CI 0.010 to 0.627) was the only predictive factor of very early rebleeding. Blood requirement was significantly lower in the Combined group than in the Terlipressin group. Complications and 6-week survival were similar in both groups. |
1 |
| 32. Lo GH, Lai KH, Cheng JS, et al. A prospective, randomized trial of sclerotherapy versus ligation in the management of bleeding esophageal varices. Hepatology. 1995;22(2):466-471. |
Experimental-Tx |
120 patients |
To conduct a prospective, randomized trial comparing sclerotherapy and ligation in 120 patients with acute bleeding of esophageal varices. |
All the patients were cirrhotic, 59 received sclerotherapy, and 61 received ligation. Treatment was repeated regularly until the varices were obliterated. The mean follow-up period was 295 +/- 120 days and 310 +/- 105 days for the sclerotherapy and ligation groups, respectively. The control of active bleeding was 12/15 (80%) in the sclerotherapy group and 18/19 (94%) in the ligation group (P = .23). The numbers of treatment sessions required to achieve variceal obliteration were 6.5 +/- 1.2 in the sclerotherapy group and 3.8 +/- 0.4 in the ligation group (P < .001). Recurrent bleeding from the gastrointestinal tract was 51% in the sclerotherapy group compared with 33% in the ligation group (P < .05). Recurrent bleeding from esophageal varices was 36% in the sclerotherapy group and 11% in the ligation group (P < .01). However, bleeding from ectopic varices and congestive gastropathy was less common in the sclerotherapy group (7%) than in the ligation group (18%) (P = .05). Significant complications were encountered in 19% of the sclerotherapy group and in 3.3% of the ligation group (P < .01). Comparison of Kaplan-Meier estimates of time to death of both groups showed a significantly lower mortality in the ligation group (P = .011). |
1 |
| 33. Masci E, Stigliano R, Mariani A, et al. Prospective multicenter randomized trial comparing banding ligation with sclerotherapy of esophageal varices. Hepatogastroenterology. 1999;46(27):1769-1773. |
Experimental-Tx |
100 patients |
To compare EVL with EVS in a prospective randomized trial in patients with previous esophageal bleeding proved by endoscopy. End points were rebleeding rate and death during a short (eradication period) or long-term follow-up (> 1 year). |
No differences were observed between the two groups regarding age, sex and Child class. One patient dropped out in the EVL group and 6 in the EVS group. Eradication was obtained in 44 (88%) with EVL and 41 (82%) with EVS with a mean of 3.41 and 5.29 treatments (p<0.001), respectively. Rebleeding occurred during eradication in 6 patients (12%) in the EVL group and 21 (42%) in the EVS group (p=0.001); after eradication, 7 patients (14%) rebled in the EVL group and 4 (8%) in the EVS group (not significant). Non-variceal bleeding was observed in 5 patients (2 EVL and 3 EVS) during follow-up. Two patients in the EVL group died after variceal rebleeding; 3 died of gastric bleeding; and, 15 from non-hemorrhagic events (8 EVL and 7 EVS). In the EVL group 14 patients had recurrent varices and 7 rebled; in the EVS group 11 recurred, with rebleeding in 5. Major complications were fewer in the EVL group (1 stenosis, 4 chronic ulcers) compared to 18 patients in the EVS group (9 stenosis and 9 chronic ulcers) (p<0.005). |
1 |
| 34. Van Stiegmann G, Isshi K. Elastic band ligation for bleeding esophagogastric varices. Hepatogastroenterology. 1997;44(15):620-624. |
Review/Other-Tx |
N/A |
To show that ligation appears superior to sclerotherapy for long-term prevention of recurrent variceal bleeding, requires fewer treatment sessions to eradicate varices, is associated with fewer bleeding and non-bleeding complications of treatment, and results in improved survival. |
Results from the synchronous combination of elastic band ligation with sclerotherapy do not appear to be superior to those obtainable with those from endoscopic ligation used alone. |
4 |
| 35. Ferrari AP, de Paulo GA, de Macedo CM, Araujo I, Della Libera E, Jr. Efficacy of absolute alcohol injection compared with band ligation in the eradication of esophageal varices. Arq Gastroenterol. 2005;42(2):72-76. |
Experimental-Tx |
46 patients |
To compare two techniques of endoscopic esophageal varices eradication: sclerotherapy with absolute alcohol and banding ligation. |
Both groups were similar except that male gender was more common in the sclerotherapy group. There was no statistical difference regarding variceal eradication (78.3% in sclerotherapy group vs 73.9% in the ligation group), recurrence (26.7% vs 42.9%, respectively) and death related to any cause (21.7% vs 13.9%). In the sclerotherapy group more sessions were need to obtain complete variceal eradication. In this group we did observe a high re-bleeding rate (34.8%) and more ulcers associated with retrosternal pain right after the procedure. There was no difference regarding overall morbidity and mortality. |
1 |
| 36. Santos MM, Tolentino LH, Rodrigues RA, et al. Endoscopic treatment of esophageal varices in advanced liver disease patients: band ligation versus cyanoacrylate injection. Eur J Gastroenterol Hepatol. 2011;23(1):60-65. |
Experimental-Tx |
38 patients |
To compare VBL and CI in the treatment of EV in patients with advanced liver disease. |
Thirty-eight patients with medium or large EV and Child-Pugh index of at least eight were randomized into two groups: VBL (n=20) and CI (n=18). The patients were followed-up for at least 6 months after the end of treatment. Main outcomes were eradication, bleeding, mortality, complication, and recurrence rates. RESULTS: Variceal eradication rates were similar in the VBL and CI groups (90 vs. 72%, P=0.39). Mean number of sessions until eradication was 3.17 and 3, respectively. Bleeding episodes until eradication were equally observed in both groups (P=0.17). Mortality (55 vs. 56%, P=0.52) and major complication rates (5 and 17%, P=0.32) were similar. Chest pain with dysphagia was more frequent in the CI group (55.6 vs. 10%, P=0.004). A higher risk of variceal recurrence was observed in the CI group (33 vs. 57%, P=0.04). |
1 |
| 37. Villanueva C, Piqueras M, Aracil C, et al. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006;45(4):560-567. |
Experimental-Tx |
30 patients |
To compare the efficacy and safety of variceal ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin. |
Therapeutic failure occurred in 21 patients treated with sclerotherapy (24%) and in nine treated with ligation (10%) (RR=2.4, 95% CI=1.1-4.9). Failure to control bleeding occurred in 15% vs 4%, respectively (P=0.02). Treatment group, shock and HVPG >16 mmHg were independent predictors of failure. Side-effects occurred in 28% of patients receiving sclerotherapy vs 14% with ligation (RR=1.9, 95% CI=1.1-3.5), being serious in 13% vs 4% (P=0.04). Six-week survival probability without therapeutic failure was better with ligation (P=0.01). |
1 |
| 38. Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding. A meta-analysis. Ann Intern Med. 1995;123(4):280-287. |
Meta-analysis |
7 RCTs; 547 patients |
To compare the effect of endoscopic ligation with that of sclerotherapy in the treatment of patients with bleeding esophageal varices |
Ligation therapy compared with sclerotherapy reduced the rebleeding rate (odds ratio, 0.52 [95% CI, 0.37 to 0.74]), the mortality rate (odds ratio, 0.67 [CI, 0.46 to 0.98]), and the rate of death due to bleeding (odds ratio, 0.49 [CI, 0.24 to 0.996]). Four patients would need to be treated with ligation instead of sclerotherapy to avert one rebleeding episode, and 10 would need to be treated with ligation instead of sclerotherapy to prevent one death. Esophageal strictures occurred less frequently with ligation (odds ratio, 0.10 [CI, 0.03 to 0.29]), but no significant differences were seen between treatments for pulmonary infections or bacterial peritonitis. Additionally, the number of endoscopic treatment sessions required to achieve variceal obliteration was lower with ligation than with sclerotherapy. |
M |
| 39. Ohmoto K, Yoshioka N, Tomiyama Y, et al. Improved prognosis of cirrhosis patients with esophageal varices and thrombocytopenia treated by endoscopic variceal ligation plus partial splenic embolization. Dig Dis Sci. 2006;51(2):352-358. |
Experimental-Tx |
84 patients |
To assess the efficacy of the combination of endoscopic variceal ligation (EVL) and partial splenic embolization (PSE) compared with EVL alone in cirrhosis patients with thrombocytopenia. |
Comparison between combined treatment and variceal ligation alone by multivariate analysis showed a hazard ratio of 0.44 for the recurrence of varices (P = 0.02), 0.19 for progression to variceal bleeding (P = 0.01), and 0.31 for death (P = 0.04). |
1 |
| 40. Taniai N, Onda M, Tajiri T, Toba M, Yoshida H. Endoscopic variceal ligation (EVL) combined with partial splenic embolization (PSE). Hepatogastroenterology. 1999;46(29):2849-2853. |
Observational-Tx |
89 patients |
To investigate the effectiveness of reducing the recurrence rate of esophageal varices by combining partial splenic embolization (PSE) with endoscopic variceal ligation (EVL). |
The cumulative recurrence rates at 6 months were 21.1% in the PSE+EVL group, 58.1% in the EVL group and 32.5% in the EIS group. Those at 1 year were 37.0%, 70.7% and 50.2%, respectively, and those at 2 years were 58.1%, 80.4% and 73.0%, respectively. For all 3 time periods, recurrence rates of the PSE+EVL group were significantly lower than those of the EVL group (p=0.042). Cumulative rates in the PSE+EVL group tended to be lower than those in the EIS group. Further analysis was made on the comparative recurrence rates of the 3 groups, according to Child's classification. The cumulative recurrence rates in Child A cases did not significantly differ between the 3 groups. Cumulative rates in Child B cases were significantly lower in the PSE+EVL group than in the EVL group (p=0.032), and those in the PSE+EVL group tended to be lower than those in the EIS group. These trends were observed between the PSE+EVL group and the EVL group in Child C cases, while cumulative rates did not show differences between the PSE+EVL group and the EIS group. |
4 |
| 41. Taniai N, Onda M, Tajiri T, Yoshida H, Mamada Y. Combined endoscopic and radiologic intervention to treat esophageal varices. Hepatogastroenterology. 2002;49(46):984-988. |
Experimental-Tx |
133 patients |
To investigate the impact on long-term outcome of combining interventional radiologic procedures with endoscopic therapy. |
Bleeding rates were 24.4% in the endoscopy group and 25.4% in the combined therapy group. Retreatment rates at 1, 3, and 5 years for the endoscopy group versus the combined therapy group were 40.7% versus 30.3%, 72.0% versus 67.5%, and 88.2% versus 80.5%, respectively, representing no significant difference between two groups. However, cumulative retreatment rates in Child's class C cases were significantly lower in the combined therapy group than in the endoscopy group (P = 0.025). Patients who had combined therapy which included all embolizing techniques showed significantly lower retreatment rates than patients treated with endoscopy alone (P = 0.05). |
2 |
| 42. D'Amico G, Pagliaro L, Bosch J. The treatment of portal hypertension: a meta-analytic review. Hepatology. 1995;22(1):332-354. |
Review/Other-Tx |
N/A |
To perform a systematic review of available studies from the Cochrane Library and MEDLINE. |
Twelve studies were identified including 943 patients. Pooled odds ratios for bleeding for the 3 hemodynamic targets were, respectively, 0.21 (95% CI: 0.10-0.45; P = .0001), 0.25 (95% CI: 0.11-0.56; P = .001), and 0.17 (95% CI: 0.09-0.33; P = .001). A significant heterogeneity was found for the 2 last estimates, and meta-regression analysis showed that this was caused by an exceedingly long interval between HVPG measurements in 1 study. After exclusion of that study, heterogeneity disappeared, and the pooled odds ratios were, respectively, 0.19 (95% CI: 0.11-0.34; P = .0001) and 0.14 (95% CI: 0.09-0.21; P = .0001). The beneficial effect of HVPG reduction for first bleeding was similar to that for recurrent bleeding. Mortality was significantly reduced for HVPG reduction by >/=20% or to </=12 mm Hg (pooled odds ratio, 0.39; 95% CI: 0.19-0.81, P = .012). |
4 |
| 43. Jalan R, John TG, Redhead DN, et al. A comparative study of emergency transjugular intrahepatic portosystemic stent-shunt and esophageal transection in the management of uncontrolled variceal hemorrhage. The American journal of gastroenterology 1995;90:1932-7. |
Observational-Tx |
58 patients |
The aim of this study was to compare transjugular intrahepatic portosystemic stent-shunt (TIPSS) with variceal band ligation (VBL) in the secondary prophylaxis of esophageal variceal hemorrhage in patients with cirrhosis. |
Seven of the 19 were considered unfit for surgery, and 12 underwent esophageal transection and devascularization. TIPSS was undertaken successfully in 17 patients, the Palmaz stent being used in 4 and the Wallstent in 13. Successful TIPSS reduced the mean portal pressure gradient from 22.2 (SE 1.2) to 9.7 (SE 0.7) mm Hg (p < 0.001). Mortality within 30 days of the initial bleed was 42% in the TIPSS group compared with 79% in the ET group (p < 0.05). Rebleeding occurred in 15.6% patients with TIPSS, compared with 26.2% in the ET group. Encephalopathy in the two groups of patients was not significantly different (TIPSS 25% and ET 22%). TIPSS was followed by active infection in 20% compared with 36% after ET. |
1 |
| 44. Henderson JM. Variceal bleeding: which shunt? Gastroenterology. 1986;91(4):1021-1023. |
Review/Other-Tx |
N/A |
No abstract available |
No abstract available |
4 |
| 45. Zakim D, Boyer TD. Hepatology : a textbook of liver disease. 4th ed. Philadelphia: Saunders; 2003. |
Review/Other-Tx |
N/A |
N/A |
N/A |
4 |
| 46. Rosemurgy AS, Frohman HA, Teta AF, Luberice K, Ross SB. Prosthetic H-graft portacaval shunts vs transjugular intrahepatic portasystemic stent shunts: 18-year follow-up of a randomized trial. J Am Coll Surg. 2012;214(4):445-453; discussion 453-445. |
Experimental-Tx |
132 patients |
To present an 18-year follow-up of a prospective randomized trial comparing TIPS with small-diameter prosthetic H-graft portacaval shunt (HGPCS) for portal decompression. |
Patient presentation, circumstances of shunting, causes of cirrhosis, severity of hepatic dysfunction (eg, Child's class, Model for End-Stage Liver Disease score), and predicted survival after shunting did not differ between patients undergoing TIPS (n = 66) or HGPCS (n = 66). Survival was significantly longer after HGPCS for patients of Child's class A (91 vs 19 months; p = 0.009) or class B (63 vs 21 months; p = 0.02). Shunt failure occurred later after HGPCS than TIPS (45 vs 22 months; p = 0.04). |
1 |
| 47. Henderson JM, Boyer TD, Kutner MH, et al. Distal splenorenal shunt versus transjugular intrahepatic portal systematic shunt for variceal bleeding: a randomized trial. Gastroenterology. 2006;130(6):1643-1651. |
Experimental-Tx |
140 patients |
To test the hypothesis that patients receiving distal splenorenal shunt (DSRS) would have significantly lower rebleeding and encephalopathy rates than transjugular intrahepatic portal systematic shunts (TIPS) in management of refractory variceal bleeding. |
No significant difference in rebleeding (DSRS 5.5%; TIPS 10.5%; P=.29) or first encephalopathy event (DSRS 50%; TIPS 50%). Survival at 2 and 5 years (DSRS 81% and 62% TIPS, 88% and 61%, respectively) were not significantly different (P=.87). Thrombosis, stenosis, and reintervention rates (DSRS 11%; TIPS 82%) were significantly (P<.001) higher in the TIPS group. Ascites, need for transplant, quality of life, and costs were not significantly different. |
1 |
| 48. Clark W, Hernandez J, McKeon B, et al. Surgical shunting versus transjugular intrahepatic portasystemic shunting for bleeding varices resulting from portal hypertension and cirrhosis: a meta-analysis. Am Surg. 2010;76(8):857-864. |
Meta-analysis |
4 studies: 67; 137; 40; 132 patients |
To examine evidence from trials comparing TIPS with surgical shunting to reassess the role of surgery in treating portal hypertension. |
Significantly better 2-year survival (OR 2.5 [1.2-5.2]) and significantly less frequent shunt failure (OR 0.3 [0.1-0.9]) were seen in patients undergoing surgical shunting compared with TIPS. |
M |
| 49. Cabrera J, Maynar M, Granados R, et al. Transjugular intrahepatic portosystemic shunt versus sclerotherapy in the elective treatment of variceal hemorrhage. Gastroenterology. 1996;110(3):832-839. |
Experimental-Tx |
63 patients |
To evaluate the efficacy and safety of TIPS in the elective treatment of hemorrhage from esophageal varices in a randomized controlled study that compared the effects of TIPS with those of endoscopic sclerotherapy (ES). |
One patient in each group died before the therapeutic procedure could be performed. During a mean follow-up period of 15 months, variceal rebleeding occurred in 51.6% of the patients in the ES group and 23% of those in the TIPS group. Uncontrolled rebleeding occurred in 10 of 31 patients in the ES group, whereas rebleeding did not occur in any patient of the TIPS group. Hepatic encephalopathy was more frequent in TIPS patients (33.3%) than in those treated by ES (13%). However, mortality was similar in both treatment groups. |
1 |
| 50. Cello JP, Ring EJ, Olcott EW, et al. Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage. A randomized, controlled trial. Ann Intern Med. 1997;126(11):858-865. |
Experimental-Tx |
49 patients |
To compare sclerotherapy with transjugular intrahepatic portosystemic shunt (TIPS) in patients with bleeding from esophageal varices. |
Mean follow-up (+/-SE) was 567 +/- 104 days in the sclerotherapy group and 575 +/- 109 days in the TIPS group. Varices were obliterated more reliably by TIPS than by sclerotherapy (P < 0.001). Patients having TIPS were significantly less likely to rebleed from esophageal varices than patients receiving sclerotherapy (3 of 24 compared with 12 of 25; P = 0.012). No other follow-up measures differed significantly between groups. A trend toward improved survival, which was not statistically significant, was noted in the TIPS group (hazard ratio, 0.53 [95% CI, 0.18 to 1.5]). |
1 |
| 51. Jalan R, Forrest EH, Stanley AJ, et al. A randomized trial comparing transjugular intrahepatic portosystemic stent-shunt with variceal band ligation in the prevention of rebleeding from esophageal varices. Hepatology. 1997;26(5):1115-1122. |
Experimental-Tx |
58 patients |
To compare transjugular intrahepatic portosystemic stent-shunt (TIPSS) with variceal band ligation (VBL) in the secondary prophylaxis of esophageal variceal hemorrhage in patients with cirrhosis. |
Results for rebleeding and mortality were analyzed on an intention-to-treat basis and using the Kaplan-Meier method. The frequency and the severity of variceal rebleeding was significantly lower in the TIPSS group (9.8%), compared with the VBL group (51.9%) (P < .0006). Although mortality rates were not significantly different, 8 of the patients who rebled in the VBL group required TIPSS therapy for uncontrolled bleeding. No significant differences were found in the frequency of other complications such as encephalopathy and sepsis. Patients in the VBL group required significantly greater time in the intensive care unit during the period of this study (<0.03). The total direct cost of treatment incurred was pound sterling 1,373 ($2,200) per patient, the cost being less in the patients treated with TIPSS compared with VBL. |
1 |
| 52. Merli M, Salerno F, Riggio O, et al. Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal bleeding in cirrhosis: a randomized multicenter trial. Gruppo Italiano Studio TIPS (G.I.S.T.). Hepatology. 1998;27(1):48-53. |
Experimental-Tx |
81 patients |
To compare the efficacy of TIPS with that of endoscopic sclerotherapy in the prevention of variceal rebleeding in cirrhosis. |
Mortality was 19% in sclerotherapy patients and 24% in TIPS patients (P = .50). Hepatic encephalopathy (HE) developed in 26% and 55%, respectively (P = .006). A separate analysis of the three strata showed that TIPS was significantly more effective than sclerotherapy (P = .026) in preventing rebleeding only in stratum I patients. |
1 |
| 53. Rossle M, Deibert P, Haag K, et al. Randomised trial of transjugular-intrahepatic-portosystemic shunt versus endoscopy plus propranolol for prevention of variceal rebleeding. Lancet. 1997;349(9058):1043-1049. |
Experimental-Tx |
126 patients |
To compare the transjugular shunt with endoscopic treatment for the prophylaxis of recurrent variceal bleeding. |
Technical success was achieved in all patients assigned to the shunt group. During follow-up, the cumulative 1-year variceal rebleeding rates in the shunted and endoscopically treated patients were 15% and 41% and the 2-year rates were 21% and 52% (p = 0.001), respectively. In nine (12%) patients from the endoscopic group treatment failed and the patients received the transjugular-shunt treatment. A total of 19 bleeding episodes from any source occurred in 15 patients in the shunt group compared with 100 episodes in 33 patients in the endoscopic group. There was no difference in survival with estimated 1-year survival rates for shunted and endoscopically treated patients of 90% and 89%, and 2-year survival rates of 79% and 82%, respectively. The incidence of clinically significant hepatic encephalopathy after 1 year was higher in the shunt group (36% vs 18%, p = 0.011). |
1 |
| 54. Sanyal AJ, Freedman AM, Luketic VA, et al. Transjugular intrahepatic portosystemic shunts compared with endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage. A randomized, controlled trial. Ann Intern Med. 1997;126(11):849-857. |
Experimental-Tx |
100 patients |
To compare the efficacy and safety of TIPS with those of endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage. |
During a mean follow-up of approximately 1000 days, recurrent gastrointestinal bleeding resulted from variceal hemorrhage (9 patients in the TIPS group and 8 in the sclerotherapy group), portal gastropathy (1 patient in each group), and gastric lipoma (0 and 1 patients, respectively). A higher mortality rate was seen with TIPS (P = 0.03). Death resulted from variceal bleeding (5 patients in the TIPS group and 3 in the sclerotherapy group), sepsis (3 and 2 patients, respectively), liver failure (2 patients in each group), hepatoma (1 and 0 patients, respectively), and hemoperitoneum (1 and 0 patients, respectively). Encephalopathy was the most common complication in the TIPS group (n = 12), and pain developing after sclerotherapy was the most common in the sclerotherapy group (n = 10). The two groups had similar rates of rehospitalization. |
1 |
| 55. Sauer P, Theilmann L, Stremmel W, Benz C, Richter GM, Stiehl A. Transjugular intrahepatic portosystemic stent shunt versus sclerotherapy plus propranolol for variceal rebleeding. Gastroenterology. 1997;113(5):1623-1631. |
Experimental-Tx |
83 patients |
To compare prevention of variceal rebleeding and mortality. |
Median observation time was in 1.6 years in the TIPS group and 1.45 years in the ES group. Cumulative rates of rebleeding were 23% in the TIPS group and 57% in the ES group (P = 0.0001). Hepatic encephalopathy was observed in 29% of the patients in the TIPS group and in 13% of those in the ES group (P = 0.041). Cumulative rates of survival were 69% in the TIPS group and 67% in the ES group (P = 0.62). Mortality rates in both groups were positively correlated with a higher Child's classification. |
1 |
| 56. Luca A, D'Amico G, La Galla R, Midiri M, Morabito A, Pagliaro L. TIPS for prevention of recurrent bleeding in patients with cirrhosis: meta-analysis of randomized clinical trials. Radiology. 1999;212(2):411-421. |
Meta-analysis |
11 trials; 750 patients |
To compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) creation with those of endoscopic treatment with or without propranolol administration (i.e, conventional treatment) on recurrent bleeding, encephalopathy, and mortality by using meta-analysis of 11 published randomized clinical trials. |
A total of 750 patients were included in 11 trials. No significant heterogeneity was found for any of the outcomes. Pooled risk differences were recurrent bleeding, -31% (95% CI, -39%, -23%); encephalopathy, +16% (95% CI, +10%, +22%); death due to all causes, +2% (95% CI, -4%, +9%); and death due to bleeding, -5% (95% CI, -11%, +6%). Clinically important complications occurred in 22% of patients and were associated with both treatments. TIPS dysfunction occurred in 55% of patients. |
M |
| 57. Papatheodoridis GV, Goulis J, Leandro G, Patch D, Burroughs AK. Transjugular intrahepatic portosystemic shunt compared with endoscopic treatment for prevention of variceal rebleeding: A meta-analysis. Hepatology. 1999;30(3):612-622. |
Meta-analysis |
11 trials; 811 patients |
To evaluate randomized trials that compare TIPS to ET and assess the prevention of re-bleeding, survival, and the effects on resource use and the quality of patients' lives. |
Variceal rebleeding was significantly more frequent with ET (47%) compared with TIPS (19%) (odds ratio [OR], 3.8; 95% confidence interval [CI], 2.8-5.2; P <.001), but there was no difference in mortality (OR, 0.97; 95% CI, 0.71-1.34). Post-treatment encephalopathy occurred significantly less often after ET (19%) than after TIPS (34%) (OR, 0.43; 95% CI, 0.30-0.60; P <.001). |
M |
| 58. Garcia-Pagan JC, Caca K, Bureau C, et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010;362(25):2370-2379. |
Experimental-Tx |
63 patients |
To determine whether early treatment with TIPS, with the use of a stent covered with extended polytetrafluoroethylene (e-PTFE), can improve outcomes in patients with cirrhosis and variceal bleeding who are at high risk for treatment failure and death. |
During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy-EBL group as compared with 1 patient in the early-TIPS group (P=0.001). The 1-year actuarial probability of remaining free of this composite end point was 50% in the pharmacotherapy-EBL group versus 97% in the early-TIPS group (P<0.001). Sixteen patients died (12 in the pharmacotherapy-EBL group and 4 in the early-TIPS group, P=0.01). The 1-year actuarial survival was 61% in the pharmacotherapy-EBL group versus 86% in the early-TIPS group (P<0.001). Seven patients in the pharmacotherapy-EBL group received TIPS as rescue therapy, but four died. The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy-EBL group than in the early-TIPS group. No significant differences were observed between the two treatment groups with respect to serious adverse events. |
1 |
| 59. Monescillo A, Martinez-Lagares F, Ruiz-del-Arbol L, et al. Influence of portal hypertension and its early decompression by TIPS placement on the outcome of variceal bleeding. Hepatology. 2004;40(4):793-801. |
Experimental-Tx |
116 patients |
To gather information about the outcome of hemodynamically defined high-risk patients treated with early portal decompression. |
Sixty-four patients had an HVPG less than 20 mm Hg (low-risk [LR] group), and 52 patients had an HVPG greater than or equal to 20 mm Hg (high-risk [HR] group). HR patients were randomly allocated into those receiving transjugular intrahepatic portosystemic shunt (TIPS; HR-TIPS group, n = 26) within the first 24 hours after admission and those not receiving TIPS (HR-non-TIPS group). The HR-non-TIPS group had more treatment failures (50% vs. 12%, P =.0001), transfusional requirements (3.7 +/- 2.7 vs. 2.2 +/- 2.3, P =.002), need for intensive care (16% vs. 3%, P <.05), and worse actuarial probability of survival than the LR group. Early TIPS placement reduced treatment failure (12%, P =.003), in-hospital and 1-year mortality (11% and 31%, respectively; P <.05). |
1 |
| 60. Angeloni S, Merli M, Salvatori FM, et al. Polytetrafluoroethylene-covered stent grafts for TIPS procedure: 1-year patency and clinical results. Am J Gastroenterol. 2004;99(2):280-285. |
Experimental-Tx |
87 patients |
To assess TIPS safety and 1-yr patency with a new commercially available PTFE-covered stent graft in comparison with a group of historical controls treated with conventional stents. |
The two groups were comparable for age, sex, etiology, and severity of cirrhosis. The 1-yr probability of remaining free of shunt dysfunction tended to be higher in the covered stent group: 76.3% (95% CI = 58.7-93.9%) versus 57.5% (95% CI = 46.6-68.4%); log rank test: p = 0.055. However, stenoses inside the stent were significantly higher in patients with bare stents (88% vs 17%), while stenoses at the hepatic or portal vein were more frequent in PTFE-covered stent-graft group (50% vs 9% and 33% vs 3%, respectively), (chi2 = 15.42; df = 2.0; p = 0.0004). Stenoses inside the covered portion of the stent did not occur. One-year cumulative rebleeding, encephalopathy, and survival were similar. |
1 |
| 61. Angermayr B, Cejna M, Koenig F, et al. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology. 2003;38(4):1043-1050. |
Observational-Tx |
508 patients |
To perform a retrospective analysis of patients receiving either bare TIPS or undergoing implantation of e-PTFE endoprostheses in several centers in Austria. |
Patients having e-PTFE stentgraft implantation had higher survival rates in all analyses. The 3-month, 1-year, and 2-year survival rates were 93%, 88%, and 76% for the e-PTFE-group and 83%, 73%, and 62% for conventional TIPS patients, respectively. Prospective study needed for validation of data. |
2 |
| 62. Bureau C, Pagan JC, Layrargues GP, et al. Patency of stents covered with polytetrafluoroethylene in patients treated by transjugular intrahepatic portosystemic shunts: long-term results of a randomized multicentre study. Liver Int. 2007;27(6):742-747. |
Experimental-Tx |
80 patients |
To study patients treated either by TIPS with a covered stent (Group 1) or an uncovered prosthesis (Group 2). |
Actuarial rates of primary patency in Groups 1 and 2 were 76% and 36%, respectively (P=0.001). Actuarial rates of being free of encephalopathy were 67% in Group 1 and 51% in Group 2 (P<0.05). Probability of survival was 58% and 45% at 2 years, respectively, in Groups 1 and 2. Improvement in TIPS patency by using covered prostheses is maintained over time with a decreased risk of encephalopathy, while the risk of death was not increased. |
1 |
| 63. Jung HS, Kalva SP, Greenfield AJ, et al. TIPS: comparison of shunt patency and clinical outcomes between bare stents and expanded polytetrafluoroethylene stent-grafts. J Vasc Interv Radiol. 2009;20(2):180-185. |
Observational-Tx |
81 patients |
To compare shunt patency and clinical outcomes in two groups of patients who received a transjugular intrahepatic portosystemic shunt (TIPS): one group with bare stents and one with expanded polytetrafluoroethylene stent-grafts. |
In the bare stent group, primary shunt patency rates were 63%, 48%, and 24% at 3, 6, and 12 months, respectively. Secondary patency rates were 75% and 62% at 3 and 6 months, respectively. In the stent-graft group, primary patency rates were 94%, 67%, and 38% at 3, 6, and 12 months, respectively. Secondary patency rates were 100% and 92% at 3 and 6 months, respectively. All stent patency rates were higher in the stent-graft group, but only the difference in the 3-month primary patency rate (63% vs 94%) reached significance (P = .03). In patients with variceal bleeding as well as those with ascites, early and overall clinical success rates were higher in the stent-graft group, but only the 3-month and 12-month differences were statistically significant. |
2 |
| 64. Rossi P, Salvatori FM, Fanelli F, et al. Polytetrafluoroethylene-covered nitinol stent-graft for transjugular intrahepatic portosystemic shunt creation: 3-year experience. Radiology. 2004;231(3):820-830. |
Experimental-Tx |
53 patients |
To prospectively evaluate the use of a recently developed expanded polytetrafluoroethylene (PTFE)-covered nitinol stent-graft in preventing the need for repeated intervention after transjugular intrahepatic portosystemic shunt (TIPS) creation. |
A technical success rate of 100% was obtained, with an early clinical success rate of 96.2%. During the follow-up period, the recurrence rate was 3.4% (one of 29 patients) for bleeding and 9.0% (two of 22 patients) for ascites. Shunt malfunction occurred in nine of 53 patients (16.9%); in one of these nine patients, shunt occlusion was evident after revision, and a parallel shunt was created. The 1-year primary and secondary patency rates were 83.8% and 98.1%, respectively. In this series, the incidence of encephalopathy (included even as a single short-lived episode) was 47.1% (25 of 53 patients). The 30-day mortality rate was 3.8% (two of 53), and the late mortality rate was 17.3% (eight of 46), excluding seven patients who underwent transplantation. |
2 |
| 65. Saad WE, Darwish WM, Davies MG, Waldman DL. Stent-grafts for transjugular intrahepatic portosystemic shunt creation: specialized TIPS stent-graft versus generic stent-graft/bare stent combination. J Vasc Interv Radiol. 2010;21(10):1512-1520. |
Observational-Tx |
121 patients |
To compare functional and anatomic outcomes of transjugular intrahepatic portosystemic shunts (TIPSs) created with the specialized Viatorr stent versus a Wallstent/Fluency stent combination. |
A total of 126 TIPSs created with stent-grafts were found: 28 with Fluency stents, 93 with Viatorr devices, and five combined. No significance in demographic factors or PSGs was found among groups (P > .05). Major encephalopathy rates were 3.6% and 4.3% in the Fluency and Viatorr groups, respectively (P = 1.000). Hemodynamic success rates were 93% and 98% in the Fluency and Viatorr groups, respectively (P = .099). The primary unassisted patency rates at 6, 9, and 12 months were 87%, 81%, and 81%, respectively, in the Fluency group and 95%, 93%, and 89%, respectively, in the Viatorr group (P = .03). Portal and hepatic end stenoses were the causes of TIPS narrowing in the Fluency and Viatorr groups, respectively. |
2 |
| 66. Garcia-Pagan JC, Di Pascoli M, Caca K, et al. Use of early-TIPS for high-risk variceal bleeding: results of a post-RCT surveillance study. J Hepatol. 2013;58(1):45-50. |
Observational-Tx |
75 patients |
To assess whether results are similar in clinical practice outside RCTs based on a recent randomized international clinical trial (RCT), in high-risk patients with cirrhosis and acute variceal bleeding, the early creation of a transjugular intrahepatic portosystemic shunt (TIPS) with the use of stents covered with polytetrafluoroethylene (e-PTFE) is associated with marked and significant reductions in both treatment failure and mortality. |
Patients treated with early-TIPS had a much lower incidence of failure to control bleeding or rebleeding than patients receiving drug+ET (3 vs. 15; p <0.001). The 1-year actuarial probability of remaining free of this composite end point was 93% vs. 53% (p <0.001). The same was observed in mortality (1-year actuarial survival was 86% vs. 70% respectively; p=0.056). Actuarial curves of failure to control bleeding+rebleeding and of survival were well within the confidence intervals of those observed in the RCT. |
2 |
| 67. Rudler M, Rousseau G, Thabut D. Salvage transjugular intrahepatic portosystemic shunt followed by early transplantation in patients with Child C14-15 cirrhosis and refractory variceal bleeding: a strategy improving survival. Transpl Int. 2013;26(6):E50-51. |
Review/Other-Tx |
N/A |
No abstract available |
No abstract available |
4 |
| 68. Halabi SA, Sawas T, Sadat B, et al. Early TIPS versus endoscopic therapy for secondary prophylaxis after management of acute esophageal variceal bleeding in cirrhotic patients: a meta-analysis of randomized controlled trials. J Gastroenterol Hepatol. 2016;31(9):1519-1526. |
Meta-analysis |
9 trials; 608 patients |
To evaluate the safety and efficacy of early TIPS versus endoscopic therapy for secondary prophylaxis after acute esophageal variceal bleeding in cirrhotic patients. |
Nine randomized controlled trials involving 608 cirrhotic patients were identified. Early TIPS was associated with a significant risk reduction in 1-year mortality (RR, 0.68; 95% CI, 0.49-0.96; P = 0.03) and 1-year incidence of variceal rebleeding (RR, 0.28; 95% CI, 0.20-0.40; P < 0.001) without significant heterogeneity among studies (I(2) = 30% and 47%, respectively). No significant difference in the incidence of hepatic encephalopathy at 1 year was observed (RR, 1.36; 95% CI, 0.72-2.56; P = 0.34); however, there was significant heterogeneity among studies (I(2) = 68%). |
M |
| 69. Pomier-Layrargues G, Villeneuve JP, Deschenes M, et al. Transjugular intrahepatic portosystemic shunt (TIPS) versus endoscopic variceal ligation in the prevention of variceal rebleeding in patients with cirrhosis: a randomised trial. Gut. 2001;48(3):390-396. |
Experimental-Tx |
80 patients |
To compare the two year survival and rebleeding rates in cirrhotic patients treated by either variceal band ligation or TIPS for variceal bleeding. |
Mean follow up was 581 days in the ligation group and 678 days in the TIPS group. The two year survival rate was 57% in the TIPS group and 56% in the ligation group (NS); the incidence of variceal rebleeding after two years was 18% in the TIPS group and 66% in the ligation group (p<0.001). Uncontrolled rebleeding occurred in 11 patients in the ligation group (eight were rescued by emergency TIPS) but in none of the TIPS group. The incidence of encephalopathy at two years was 47% in the TIPS group and 44% in the ligation group (NS). |
1 |
| 70. Rosemurgy AS, Bloomston M, Clark WC, Thometz DP, Zervos EE. H-graft portacaval shunts versus TIPS: ten-year follow-up of a randomized trial with comparison to predicted survivals. Ann Surg 2005;241:238-46. |
Review/Other-Tx |
132 patients (92 males and 40 females) |
To report long-term outcome of patients undergoing prosthetic 8-mm H-graft portacaval shunts (HGPCS) or transjugular intrahepatic portasystemic stent shunt (TIPS) and to compare actual with predicted survival data. |
Patients undergoing TIPS (N = 66) or HGPCS (N = 66) were very similar by Child's class and MELD scores and predicted survival. After TIPS (P = 0.01) and HGPCS (P = 0.001), actual survival was superior to predicted survival. Through 24 months, actual survival after HGPCS was superior to actual survival after TIPS (P = 0.04). Compared with TIPS, survival was superior after HGPCS for patients of Child's class A and B (P = 0.07) and with MELD scores less than 13 (P = 0.04) with follow-up at 5 to 10 years. Shunt failure was less following HGPCS (P < 0.01). |
4 |
| 71. Augustin S, Altamirano J, Gonzalez A, et al. Effectiveness of combined pharmacologic and ligation therapy in high-risk patients with acute esophageal variceal bleeding. The American journal of gastroenterology 2011;106:1787-95. |
Experimental-Tx |
162 patients |
To test the hypothesis that the mortality of high-risk patients with acute esophageal variceal bleeding selected by clinical criteria treated with the current recommended standard of care (i.e., vasoactive drugs plus antibiotics plus endoscopic ligation) is much lower than what has been previously suggested. |
Among the 162 patients receiving emergency ligation, 14% rebled and 16% died. Standard therapy was very effective in all risk strata, even in high-risk patients, specially if eligible for therapeutic trials (child <14, age =75 years, creatinine =3.0 mg/dl, no hepatocellular carcinoma, or portal thrombosis), showing this stratum a 10% mortality. In patients receiving ligation, Child-Pugh C patients with baseline creatinine <1.0 mg/dl showed similar mortality to Child-Pugh A or B patients (8% vs. 7%, respectively). Only Child-Pugh C patients with creatinine =1.0 were at a significant higher risk (Child-Pugh C: 46% mortality if creatinine =1.0 vs. 8% if creatinine <1.0, P=0.006). |
2 |
| 72. Reverter E, Tandon P, Augustin S, et al. A MELD-based model to determine risk of mortality among patients with acute variceal bleeding. Gastroenterology. 2014;146(2):412-419 e413. |
Review/Other-Tx |
178 patients |
To improve determination of risk for patients with acute variceal bleeding (AVB). |
Among study subjects, the 6-week mortality rate was 16%. MELD was the best model in terms of discrimination; it was recalibrated to predict the 6-week mortality rate with logistic regression (logit, -5.312 + 0.207 * MELD; bootstrapped R(2), 0.3295). MELD values of 19 or greater predicted 20% or greater mortality, whereas MELD scores less than 11 predicted less than 5% mortality. The model performed well for patients from Canada at all risk levels. In the Spanish validation set, in which all patients were treated with banding ligation, MELD predictions were accurate up to the 20% risk threshold. |
4 |
| 73. Conejo I, Guardascione MA, Tandon P, et al. Multicenter External Validation of Risk Stratification Criteria for Patients With Variceal Bleeding. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2018;16:132-39 e8. |
Observational-Tx |
915 Patients |
To evaluate the external validity of 3 criteria for risk stratification in acute variceal bleeding (AVB) (early TIPS criteria, ChildC-C1, and MELD19) in a large cohort of patients treated with the current standard of care. The study also aimed to evaluate the risk in Child-Pugh B patients with or without active bleeding. |
Among 915 patients with AVB, 18% died within 6 weeks. Among the 523 patients who met the early TIPS criteria, 17% died within 6 weeks. All 3 rules discriminated patients at high risk of death from those with low risk: 28.3% of the patients classified as high risk by the early TIPS criteria died whereas only 7.0% of patients classified as low risk died; 46.0% of patients classified as high risk by the MELD19 criteria died vs 8.1% of patients classified as low risk; 51.9% of patients classified as high risk by the ChildC-C1 criteria died compared with 10.9% of patients classified as low risk. Mortality was significantly lower among patients with Child-Pugh class B (11.7%) than with Child-Pugh class C (35.6%) (P = .001). Mortality was similar between patients with Child-Pugh class B cirrhosis with or without active bleeding (11.7%). Patients with Child-Pugh class A cirrhosis or MELD scores of 11 or less had low mortality (2%-4%), patients with Child-Pugh class B cirrhosis or MELD scores of 12 to 18 had intermediate mortality (10%-12%), and patients with Child-Pugh class C cirrhosis or MELD scores of 19 or more had high mortality (22%-46%). |
3 |
| 74. Al Sibae MR, Cappell MS. Accuracy of MELD scores in predicting mortality in decompensated cirrhosis from variceal bleeding, hepatorenal syndrome, alcoholic hepatitis, or acute liver failure as well as mortality after non-transplant surgery or TIPS. Dig Dis Sci 2011;56:977-87. |
Review/Other-Tx |
N/A |
To systematically review literature on use of model for end-stage liver disease (MELD) score to determine severity and prognosis of liver disease in various clinical situations and to evaluate its use in decisions regarding therapeutic interventions. |
The MELD score, a prospectively developed and validated scale for severity of end-stage liver disease, utilizes serum bilirubin, serum creatinine, and international normalized ratio to predict mortality in cirrhotic patients. It has proven clinically useful in increasingly varied clinical situations. The United Network for Organ Sharing uses MELD scores, with bonus points assigned for hepatocellular cancer, to prioritize allocation of deceased donor livers for liver transplantation. This work reviews recent data demonstrating that MELD scores relatively accurately predict mortality in patients with variceal bleeding, hepatorenal syndrome, alcoholic hepatitis, and acute liver failure, as well as assess risks of non-liver transplantation surgery or transjugular intrahepatic portosystemic shunts in cirrhotic patients. MELD scores fail to predict mortality in about 15% of patients with end-stage liver disease. Incorporation of additional parameters, including serum sodium level, serum albumin level, glucose intolerance, or APACHE II score, may potentially improve prognostic accuracy. |
4 |
| 75. Casadaban LC, Parvinian A, Zivin SP, et al. MELD score for prediction of survival after emergent TIPS for acute variceal hemorrhage: derivation and validation in a 101-patient cohort. Ann Hepatol 2015;14:380-8. |
Observational-Tx |
295 patients |
To identify predictive factors for survival among emergent transjugular intrahepatic portosystemic shunt (TIPS) patients, and to substantiate MELD for outcomes prognostication in this population. |
101 patients with acute life threatening variceal hemorrhage underwent emergent TIPS (defined by failed endoscopic therapy for active bleeding, acute hemoglobin drop, = 2-unit transfusion requirement, and/or vasopressor need) at between 1998-2013. Demographic, clinical, laboratory, and procedure parameters were analyzed for correlation with mortality using Cox proportional hazards regression to derive the prognostic value of MELD constituents. Area under receiver operator characteristic (AUROC) curves was used to assess the capability of MELD prediction of mortality. TIPS were created 119 ± 167 h after initial bleeding events. Hemodynamic success was achieved in 90%. Median final portosystemic pressure gradient was 8 mmHg. Variceal rebleeding incidence was 21%. The four original MELD components showed significant correlation with mortality on multivariate Cox regression: baseline bilirubin (regression coefficient 0.366), creatinine (0.621), international normalized ratio (1.111), and liver disease etiology (0.808), validating the MELD system for emergent cases. No other significant predictive parameters were identified. MELD was an excellent predictor of 90-day mortality in the emergent TIPS population (AUROC = 0.842, 95% CI 0.755-0.928). |
2 |
| 76. Gaba RC, Couture PM, Bui JT, et al. Prognostic capability of different liver disease scoring systems for prediction of early mortality after transjugular intrahepatic portosystemic shunt creation. Journal of vascular and interventional radiology : JVIR 2013;24:411-20, 20 e1-4; quiz 21. |
Observational-Tx |
211 patients |
To compare the performance of various liver disease scoring systems in predicting early mortality after transjugular intrahepatic portosystemic shunt (TIPS) creation. |
TIPS were successfully created for variceal hemorrhage (n = 121), ascites (n = 72), hepatic hydrothorax (n = 15), and portal vein thrombosis (n = 3). All scoring systems had a significant association with 30-day and 90-day mortality (P<.050 in each case) on multivariate analysis. Based on 30-day and 90-day AUROC, MELD (0.878, 0.816) and MELD-Na (0.863, 0.823) scores had the best capability to predict early mortality compared with bilirubin (0.786, 0.749), CP (0.822, 0.771), Emory (0.786, 0.681), PI (0.854, 0.760), APACHE 2 (0.836, 0.735), and BOTEM (0.798, 0.698), with statistical superiority over bilirubin, Emory, and BOTEM scores. |
3 |
| 77. Heinzow HS, Lenz P, Kohler M, et al. Clinical outcome and predictors of survival after TIPS insertion in patients with liver cirrhosis. World J Gastroenterol 2012;18:5211-8. |
Observational-Tx |
101 patients |
To determine the clinical outcome and predictors of survival after transjugular intrahepatic portosystemic stent shunt (TIPS) implantation in cirrhotic patients. |
No difference could be seen in terms of age, sex, underlying disease or degree of portal pressure gradient (PPG) reduction between the ascites and the bleeding group. The PPG significantly decreased from 23.4 ± 5.3 mmHg (VB) vs. 22.1 ± 5.5 mmHg (RA) before TIPS to 11.8 ± 4.0 vs. 11.7 ± 4.2 after TIPS implantation (P = 0.001 within each group). There was a tendency towards more patients with stage CHILD A in the bleeding group compared to the ascites group (24 vs 6, P = 0.052). The median survival for the ascites group was 29 mo compared to > 60 mo for the bleeding group (P = 0.009). The number of radiological controls for stent patency was 6.3 for bleeders and 3.8 for ascites patients (P = 0.029). Kaplan-Meier calculation indicated that stent occlusion at first control (P = 0.027), ascites prior to TIPS implantation (P = 0.009), CHILD stage (P = 0.013), MELD score (P = 0.001) and those patients not having undergone liver transplantation (P = 0.024) were significant predictors of survival. In the Cox regression model, stent occlusion (P = 0.022), RA (P = 0.043), CHILD stage (P = 0.015) and MELD score (P = 0.004) turned out to be independent prognostic factors of survival. The anticoagulation management (P = 0.097), the porto-systemic pressure gradient (P = 0.460) and rebleeding episodes (P = 0.765) had no significant effect on the overall survival. |
2 |
| 78. Montgomery A, Ferral H, Vasan R, Postoak DW. MELD score as a predictor of early death in patients undergoing elective transjugular intrahepatic portosystemic shunt (TIPS) procedures. Cardiovascular and interventional radiology 2005;28:307-12. |
Observational-Tx |
119 patients |
To Evaluate the MELD score as a predictor of 30-day mortality in patients undergoing elective TIPS procedures. |
Technical success rate was 100%. The early death rate was 10.9% (13/119). The mean MELD scores before TIPS were 19.4 (+/- 5.9) (EDG) and 14 (+/- 4.2) (SG) (p = 0.025). The early death rate was highest in the pre-TIPS MELD > 24 subgroup. The Child-Pugh scores were 9.0 (+/- 1.6) (SG) and 9.8 +/- 1.06 (EDG) (p = 0.08). The mean portosystemic gradients before TIPS were 20.5 (+/- 7.7) mmHg (EDG) and 22.7 (+/- 7.3) (SG) (p > 1) and the mean portosystemic gradients after TIPS were 6.5 (+/- 3.5) (EDG) and 6.9 (+/- 2.4) (SG) (p > 1). The mean procedural times were 95.6 (+/- 8.4) min (EDG) and 89.2 (+/- 7.5) min (SG) (p > 1). No early death was attributed to a fatal complication during TIPS. |
3 |
| 79. Tzeng WS, Wu RH, Lin CY, et al. Prediction of mortality after emergent transjugular intrahepatic portosystemic shunt placement: use of APACHE II, Child-Pugh and MELD scores in Asian patients with refractory variceal hemorrhage. Korean J Radiol 2009;10:481-9. |
Observational-Tx |
107 patients (74 males, 33 females) |
To determine if existing methods of grading liver function that have been developed in non-Asian patients with cirrhosis can be used to predict mortality in Asian patients treated for refractory variceal hemorrhage by the use of the transjugular intrahepatic portosystemic shunt (TIPS) procedure. |
No patient died during the TIPS procedure, but 82 patients died during the follow-up period. Thirty patients died within 30 days after the TIPS procedure; 37 patients died within 60 days and 53 patients died within 360 days. Univariate analysis indicated that hepatorenal syndrome, use of inotropic agents and mechanical ventilation were associated with elevated 30-day mortality (p < 0.05). Multivariate analysis showed that a Child-Pugh score > 11 or an MELD score > 20 predicted increased risk of death at 30, 60 and 360 days (p < 0.05). APACHE II scores could only predict mortality at 360 days (p < 0.05). |
2 |
| 80. Dechene A, El Fouly AH, Bechmann LP, et al. Acute management of refractory variceal bleeding in liver cirrhosis by self-expanding metal stents. Digestion. 2012;85(3):185-191. |
Review/Other-Tx |
8 patients; 9 events |
To evaluate the implantation of self-expanding metal stents (SEMS) for the management of therapy-refractory variceal bleeding. |
Stenting resulted in immediate hemostasis in all cases without recurrent bleeding with SEMS in situ. After stabilization, 1 patient was treated by transjugular intrahepatic portosystemic shunt (TIPS) and after the second bleeding episode by TIPS dilation. One patient underwent orthotopic liver transplantation (OLT). The remaining patients were treated with standard drug regimens to reduce portal pressure. The SEMS were removed after a median of 11 days. No acute hemorrhage was noted on stent retrieval. While no early rebleeding occurred in the patients after TIPS implant, TIPS dilation or OLT, 3 out of 5 patients on conservative treatment experienced recurrence of VB within 9 days after SEMS removal. |
4 |
| 81. Fierz FC, Kistler W, Stenz V, Gubler C. Treatment of esophageal variceal hemorrhage with self-expanding metal stents as a rescue maneuver in a swiss multicentric cohort. Case Rep Gastroenterol. 2013;7(1):97-105. |
Review/Other-Tx |
7 patients; 9 events |
To share our data as a high-risk patient collective. |
Thanks to their safety and easy handling, SEMS are an interesting alternative to balloon tamponade as a bridging intervention to definitive therapy including the pre-hospital setting. |
4 |
| 82. Wright G, Lewis H, Hogan B, Burroughs A, Patch D, O'Beirne J. A self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc. 2010;71(1):71-78. |
Review/Other-Tx |
10 patients |
To evaluate the safety and efficacy of a novel removable self-expanding metal stent in the management of refractory variceal bleeding. |
Stent insertion was successful in 9 of 10 patients. Failure to control bleeding was observed in 3 patients (2 with gastric varices), with control of bleeding in the remainder. Overall survival at 42 days was 50%. Six patients survived the acute bleeding episode and had stents removed endoscopically at a median of 9 days after insertion. One patient had a minor ulceration of the esophagus caused by stent insertion. |
4 |
| 83. Zakaria MS, Hamza IM, Mohey MA, Hubamnn RG. The first Egyptian experience using new self-expandable metal stents in acute esophageal variceal bleeding: pilot study. Saudi J Gastroenterol. 2013;19(4):177-181. |
Review/Other-Tx |
20 patients |
To investigate the effectiveness and safety of the new self-expandable metal stents (SEMS) in the initial control of acute variceal bleeding. |
Stent deployment was successful in 15 of 16 patients (93.75%). Technical errors were reported in 3 (18.75%) patients. Initial control of variceal bleeding was reported in 14 (out of 16) (87.5%) patients. The mean duration of the procedure was 10 (+/-6) min. Mortality was reported in 4 (25.0%) patients. |
4 |
| 84. Zehetner J, Shamiyeh A, Wayand W, Hubmann R. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc. 2008;22(10):2149-2152. |
Review/Other-Tx |
34 patients |
To assess the SX-ELLA Stent Danis Set (which has a self-expanding metal stent) instead of a balloon probe for compression of esophageal varices. |
For all 34 patients, the implantation of the esophageal stent succeeded in stopping ongoing bleeding. No stent-related complications occurred during or after stent implantation. No bleeding recurrence was observed during the stent implantation (median time, 5 days; range 1-14 days). For all the patients, the stent could be extracted by endoscopy without any complications using an extractor. Nine patients died of hepatic failure within 30 days after the procedure. No rebleeding occurred. |
4 |
| 85. Hermie L, Dhondt E, Vanlangenhove P, Hoste E, Geerts A, Defreyne L. Model for end-stage liver disease score and hemodynamic instability as a predictor of poor outcome in early transjugular intrahepatic portosystemic shunt treatment for acute variceal hemorrhage. European journal of gastroenterology & hepatology 2018;30:1441-46. |
Observational-Tx |
32 patients |
To evaluate the outcome of early transjugular portosystemic shunt (TIPS) treatment in patients with a trial-compatible high-risk variceal bleeding and secondly to disclose other predictors of early mortality. |
We noted one (3.7%) failure to control bleeding and no rebleeding during 1-year follow-up. Ten (31.3%) patients died within 6 weeks after TIPS placement. Early mortality was associated with model for end-stage liver disease (MELD) score (P=0.025), MELD score of at least 19 (P=0.008) and hemodynamic instability at time of admission (P=0.001). If hemodynamic instability is associated with a high MELD score, the 6-week mortality peaks at 77.8% (P=0.000). |
2 |
| 86. D'Amico G, De Franchis R, Cooperative Study G. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology 2003;38:599-612. |
Experimental-Tx |
465 patients |
To assess how treatments for variceal bleeding are used in clinical practice and what the posttherapeutic prognosis and prognostic indicators of upper digestive bleeding in patients with cirrhosis are. |
A training set of 291 and a test set of 174 bleeding cirrhotic patients were included. Treatment was according to the preferences of each center and the follow-up period was 6 weeks. Predictive rules for 5-day failure (uncontrolled bleeding, rebleeding, or death) and 6-week mortality were developed by the logistic model in the training set and validated in the test set. Initial treatment controlled bleeding in 90% of patients, including vasoactive drugs in 27%, endoscopic therapy in 10%, combined (endoscopic and vasoactive) in 45%, balloon tamponade alone in 1%, and none in 17%. The 5-day failure rate was 13%, 6-week rebleeding was 17%, and mortality was 20%. Corresponding findings for variceal versus nonvariceal bleeding were 15% versus 7% (P =.034), 19% versus 10% (P =.019), and 20% versus 15% (P =.22). Active bleeding on endoscopy, hematocrit levels, aminotransferase levels, Child-Pugh class, and portal vein thrombosis were significant predictors of 5-day failure; alcohol-induced etiology, bilirubin, albumin, encephalopathy, and hepatocarcinoma were predictors of 6-week mortality. Prognostic reassessment including blood transfusions improved the predictive accuracy. All the developed prognostic models were superior to the Child-Pugh score. |
2 |
| 87. Englesbe MJ, Kubus J, Muhammad W, et al. Portal vein thrombosis and survival in patients with cirrhosis. Liver Transpl 2010;16:83-90. |
Observational-Tx |
3000 patients |
To report on the survival of over 3000 adult patients with chronic liver disease who were evaluated for a liver transplant and stratified by the presence of occlusive portal vein thrombosis (PVT). |
A total of 3295 patients were analyzed, and 148 (4.5%) had PVT. Variables independently predictive of mortality from the time of liver transplant evaluation included age [hazard ratio (HR), 1.02; 95% confidence interval (CI), 1.01-1.03], Model for End-Stage Liver Disease (MELD) score (HR, 1.10; 95% CI, 1.08-1.11), hepatitis C (HR, 1.44; 95% CI, 1.24-1.68), and PVT (HR, 2.61; 95% CI, 1.97-3.51). Variables independently associated with the risk of mortality from the time of liver transplant listing included age (HR, 1.02; 95% CI, 1.01-1.03), transplantation (HR, 0.65; 95% CI, 0.50-0.81), MELD (HR, 1.08; 95% CI, 1.06-1.10), hepatitis C (HR, 1.50; 95% CI, 1.18-1.90), and PVT (1.99; 95% CI, 1.25-3.16). The presence of occlusive PVT at the time of liver transplantation was associated with an increased risk of death at 30 days (odds ratio, 7.39; 95% CI, 2.39-22.83). |
2 |
| 88. Wong F, Blendis L. Transjugular intrahepatic portosystemic shunt for refractory ascites: tipping the sodium balance. Hepatology 1995;22:358-64. |
Review/Other-Tx |
N/A |
To review the transjugular intrahepatic portosystemic shunt (TIPS) in treatment of refractory ascites. |
No results stated in abstract. |
4 |
| 89. Bilbao JI, Quiroga J, Herrero JI, Benito A. Transjugular intrahepatic portosystemic shunt (TIPS): current status and future possibilities. Cardiovascular and interventional radiology 2002;25:251-69. |
Review/Other-Tx |
N/A |
To review the current status and future possibilities of Transjugular intrahepatic portosystemic shunt (TIPS). |
No results stated in abstract. |
4 |
| 90. Nunes EL, dos Santos KR, Mondino PJ, Bastos Mdo C, Giambiagi-deMarval M. Detection of ileS-2 gene encoding mupirocin resistance in methicillin-resistant Staphylococcus aureus by multiplex PCR. Diagn Microbiol Infect Dis 1999;34:77-81. |
Experimental-Dx |
N/A |
To establish a protocol of multiplex polymerase chain reaction (MPCR) for the detection of ileS-2 gene and methicillin resistance in S. aureus, supporting an efficient treatment and control of staphylococcal infections. |
The presence of the ileS-2 gene, responsible for mupirocin resistance, in clinical isolates of methicillin-resistant Staphylococcus aureus was determined by multiplex polymerase chain reaction. Three pairs of primers were used, which yielded specific fragments of femA (encoding a unique feature of S. aureus), mecA (encoding resistance to methicillin) and ileS-2 genes. |
4 |
| 91. Ochs A. Transjugular intrahepatic portosystemic shunt. Dig Dis 2005;23:56-64. |
Review/Other-Tx |
N/A |
To summarize present knowledge about technical aspects and complications, follow-up of transjugular intrahepatic portosystemic shunt (TIPS) patients and indications. |
No results stated in abstract. |
4 |
| 92. Senzolo M, Cholongitas E, Davies N, et al. Transjugular Intrahepatic Portosystemic Shunt (TIPS), the preferred therapeutic option for Budd Chiari syndrome associated with portal vein thrombosis. The American journal of gastroenterology 2006;101:2163-4; author reply 64-5. |
Review/Other-Tx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 93. Senzolo M, Tibbals J, Cholongitas E, Triantos CK, Burroughs AK, Patch D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with and without cavernous transformation. Alimentary pharmacology & therapeutics 2006;23:767-75. |
Observational-Tx |
28 patients |
To evaluate the feasibility and efficacy of transjugular intrahepatic portosystemic shunt for portal vein thrombosis with/without cavernomatous transformation. |
Transjugular intrahepatic portosystemic shunt was attempted in 28 patients (13 cirrhotics). Indications were: presurgery/transplantation (2), worsening of ascites (2), variceal bleeding (15 – 8 elective), refractory ascites (3), portal biliopathy (3) and portal vein thrombosis complicating Budd–Chiari syndrome (2). Transjugular intrahepatic portosystemic shunt was placed successfully in 19 of 28 (73%); 23 of 28 had complete portal vein thrombosis and 9 of 23 had cavernous transformation and transjugular intrahepatic portosystemic shunt was successfully placed in six of these. In the 19 patients with transjugular intrahepatic portosystemic shunt, the mean follow-up was 18.1 months (range 5–70): six patients had stent revisions; three had liver transplantation, one died of bleeding. Most cirrhotic patients had an improvement in the Child-Pugh score. In the failed transjugular intrahepatic portosystemic shunt group, two of nine died, and three had further bleeding. |
4 |
| 94. Valentin N, Korrapati P, Constantino J, Young A, Weisberg I. The role of transjugular intrahepatic portosystemic shunt in the management of portal vein thrombosis: a systematic review and meta-analysis. European journal of gastroenterology & hepatology 2018;30:1187-93. |
Meta-analysis |
18 studies |
To conduct a systematic review and meta-analysis to evaluate the role of transjugular intrahepatic portosystemic shunt (TIPS) for the management of portal vein thrombosis (PVT) in adult patients with liver disease. |
Eighteen studies were included in the analysis. The pooled technical success rate was 86.7% [95% confidence interval (CI)=78.6-92.1%]. Rate of portal vein recanalization was 84.4% (95% CI=78.4-89.0%). The rate of complete recanalization was 73.7% (95% CI=64.3-81.3%). Portal patency was 86.9% (95% CI=79.7-91.8%). Mean change in portal pressure gradient was 14.5?mmHg (95% CI=11.3-17.7?mmHg). Hepatic encephalopathy was 25.3% (95% CI=19.2-32.6%). The number of major adverse events reported across studies was low. The majority of the analyses were not associated with substantial heterogeneity. |
Good |
| 95. Lunderquist A, Vang J. Sclerosing injection of esophageal varices through transhepatic selective catheterization of the gastric coronary vein. A preliminary report. Acta Radiol Diagn (Stockh) 1974;15:546-50. |
Review/Other-Tx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 96. Tian X, Shi Y, Hu J, Wang G, Zhang C. Percutaneous transhepatic variceal embolization with cyanoacrylate vs. transjugular intrahepatic portal systematic shunt for esophageal variceal bleeding. Hepatology international 2013;7:636-44. |
Observational-Tx |
139 patients |
To compare the long-term results of modified percutaneous transhepatic variceal embolization with cyanoacrylate (PTVE) and the transjugular intrahepatic portal systemic shunt (TIPS) for treating esophageal variceal bleeding. |
This retrospective study included 96 PTVE patients and 43 TIPS patients, with a median follow-up of 30.4 and 31.6 months in the two groups, respectively. Rebleeding occurred in 13 patients (30.2 %) in the TIPS group and in 20 patients (20.8 %) in the PTVE group (p = 0.229). For patients with model for end-stage liver disease (MELD) scores >18 at 1, 3 and 5 years, the survival rates were 84.2, 39.9 and 16.0 %, respectively, in the TIPS group, and they were 96.7, 72.0 and 36.0 %, respectively, in the PTVE group (p = 0.037). Sixteen (16.7 %) PTVE patients and 25 (58.1 %) TIPS patients developed encephalopathy (p = 0.000). Mean MELD and Child-Pugh scores improved significantly in modified PTVE patients. However, no such changes were observed in TIPS patients. |
2 |
| 97. Chu HH, Kim HC, Jae HJ, et al. Percutaneous transsplenic access to the portal vein for management of vascular complication in patients with chronic liver disease. Cardiovascular & Interventional Radiology. 35(6):1388-95, 2012 Dec.Cardiovasc Intervent Radiol. 35(6):1388-95, 2012 Dec. |
Review/Other-Tx |
9 patients |
To evaluate the safety and feasibility of percutaneous transsplenic access to the portal vein formanagement of vascular complication in patients with chronic liver diseases. |
Percutaneous transsplenic splenic vein catheterization was performed successfully in all patients. Gastric or jejunal varix embolization with glue and lipiodol mixture was performed successfully in four patients. In two patients with a massive portosystemic shunt, embolization of the shunting vessel with a vascular plug, microcoils, glue, and lipiodol mixture was achieved successfully. Portal vein recanalization was attempted in three patients with a transplanted liver; however, only one patient was treated successfully. Complete closure of the percutaneous transsplenic tract was achieved using coils and glue without bleeding complication in all patients. |
4 |
| 98. Gong GQ, Wang XL, Wang JH, et al. Percutaneous transsplenic embolization of esophageal and gastrio-fundal varices in 18 patients. World J Gastroenterol 2001;7:880-3. |
Review/Other-Tx |
18 patients |
To examine the clinical application and potential complication of percutaneous transsplenic varices embolization (PTSVE) of esophageal or gastrio-fundal varices in patients with hepatocellular carcinoma (HCC) complicated with portal vein cancerous thrombosis (PVCT). |
PTSVE were successfully performed in 16 of 18 cases, and the rate of success was 89%. After therapy erythrocyte counts decreased in all of the natunts. 5 of patients needed blood transfusion, 2 patients requiredsurgical intervention because of and 11 patients with ascites were alleviated by diuresis. Among these 18 patients, the procedure-related mortality was 11% (2/18), one died of acute hepatic failure on the forth day after procedure, another died of acute renal failure on the fifth day. The patients were follow up for 1-12 mon exceptone. 13 of them died of their tumors but none of them experienced variceal bleeding. |
4 |
| 99. Tuite DJ, Rehman J, Davies MH, Patel JV, Nicholson AA, Kessel DO. Percutaneous transsplenic access in the management of bleeding varices from chronic portal vein thrombosis. J Vasc Interv Radiol 2007;18:1571-5. |
Review/Other-Tx |
3 patients |
To examine three patients with life-threatening variceal hemorrhage secondary to portal vein (PV) thrombosis undergoing endovascular treatment via the transsplenic route. |
No results. |
4 |
| 100. Trotter J, Pieramici E, Everson GT. Chronic albumin infusions to achieve diuresis in patients with ascites who are not candidates for transjugular intrahepatic portosystemic shunt (TIPS). Dig Dis Sci. 2005;50(7):1356-1360. |
Review/Other-Tx |
19 patients |
To report our experience with the use of chronic intravenous albumin infusions to achieve diuresis in this difficult patient population and review the historic experience of chronic albumin infusions as a treatment for ascites. |
The contraindications for TIPS included the following: portal vein thrombosis, two; advanced age, one; encephalopathy, nine; hyperbilirubinemia, five; and other, two. Compared to pretreatment, posttreatment weight decreased in 17 patients, remained unchanged in 0 patients, and increased in 2 patients. The overall mean change in body weight (before vs. after therapy) was 8 lb (P < 0.05). The only significant change in biochemistry was an increase in serum albumin from 2.5 g/dl before therapy to 3.5 g/dl after therapy (P < 0.05). We conclude that (1) recurrent intravenous weekly albumin infusions resulted in significant loss of edema and ascites as measured by loss of body weight, and (2) clinicians may want to consider chronic albumin infusions for selected patients with refractory ascites who are not candidates for TIPS. |
4 |
| 101. Wong F. Management of ascites in cirrhosis. J Gastroenterol Hepatol. 2012;27(1):11-20. |
Review/Other-Tx |
N/A |
To discuss ascites as a common complication of liver cirrhosis associated with a poor prognosis. |
Significant mortality is still being observed in cirrhotic patients with ascites and relatively preserved liver and renal function, as indicated by a lower Model for End-Stage Liver Disease (MELD) score. |
4 |
| 102. Barbano B, Sardo L, Gigante A, et al. Pathophysiology, diagnosis and clinical management of hepatorenal syndrome: from classic to new drugs. Curr Vasc Pharmacol. 2014;12(1):125-135. |
Review/Other-Tx |
N/A |
To discuss advanced cirrhosis as frequently associated with renal dysfunction and update the pathophysiology, diagnosis and management of hepatorenal syndrome (HRS). |
Over the last decade, clinical strategies to prevent HRS have been improved by a better understanding of the natural history of renal failure in cirrhosis, resulting in a reduction of HRS prevalence in cirrhotic patients. Vasoconstrictor drugs may improve renal function, but the effect on mortality has not yet been established. |
4 |
| 103. Fernandez J, Monteagudo J, Bargallo X, et al. A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis. Hepatology. 2005;42(3):627-634. |
Experimental-Tx |
10 patients |
To compare the effect of albumin (10 patients) and the synthetic plasma expander hydroxyethyl starch 200/0.5 (10 patients) on the systemic hemodynamics of patients with spontaneous bacterial peritonitis. |
Treatment with albumin was associated with a significant increase in arterial pressure and a suppression of plasma renin activity, indicating an improvement in circulatory function. This occurred in the setting of a significant expansion of central blood volume (increase in cardiopulmonary pressures and atrial natriuretic factor) and an increase in systolic volume and systemic vascular resistance. In contrast, no significant changes were observed in these parameters in patients treated with hydroxyethyl starch. Von Willebrand-related antigen plasma levels significantly decreased in patients treated with albumin but not in those treated with hydroxyethyl starch. Serum nitrates and nitrites increased in patients treated with hydroxyethyl starch but not in those treated with albumin. These data suggest an effect of albumin on endothelial function. |
2 |
| 104. Guevara M, Arroyo V. Hepatorenal syndrome. Expert Opin Pharmacother. 2011;12(9):1405-1417. |
Review/Other-Tx |
N/A |
To cover the differential diagnosis between hepatorenal syndrome (HRS) and other causes of renal failure, as well as the difficulty in making a correct diagnosis, caused by the differentiation between hepatorenal syndrome and acute tubular necrosis. |
The correct diagnosis of renal failure is essential to initiate the correct treatment of this complication. In patients with HRS type 1, treatment with vasopressin and albumin is the treatment of choice; however, 50% of patients do not respond to this treatment. |
4 |
| 105. Gentilini P, Casini-Raggi V, Di Fiore G, et al. Albumin improves the response to diuretics in patients with cirrhosis and ascites: results of a randomized, controlled trial. J Hepatol. 1999;30(4):639-645. |
Experimental-Tx |
126 patients |
To investigate whether intravascular volume expansion with albumin exert beneficial effects in cirrhosis with ascites. |
The cumulative rate of response to diuretic treatment of ascites was higher (p < 0.05) and hospital stay was shorter (20 +/- 1 versus 24 +/- 2 days, p < 0.05) in group B than in group A patients. After discharge, group B patients had a lower cumulative probability of developing ascites (19%, 56%, 69% versus 30%, 79% and 82% at 12, 24 and 36 months, p < 0.02) and a lower probability of readmission to the hospital (15%, 56%, 69% versus 27%, 74% and 79%, respectively, p < 0.02). Survival was similar in the two groups. |
1 |
| 106. Romanelli RG, La Villa G, Barletta G, et al. Long-term albumin infusion improves survival in patients with cirrhosis and ascites: an unblinded randomized trial. World J Gastroenterol. 2006;12(9):1403-1407. |
Experimental-Tx |
100 patients |
To investigate the effects of long-term albumin administration on survival, recurrence of ascites and onset of other complications. |
Albumin-treated patients had significantly greater cumulative survival rate (Breslow test=7.05, P=0.0078) and lower probability of ascites recurrence (51% versus 94%, P<0.0001). Chronic albumin infusion resulted in a mean increase in survival of 16 mo. |
1 |
| 107. Wong F, Watson H, Gerbes A, et al. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut 2012;61:108-16. |
Meta-analysis |
1200 patients |
To evaluate the efficacy and safety of satavaptan in three different populations of patients with cirrhosis and ascites. |
Satavaptan was not more effective than placebo in the control of ascites in any of the populations studied as estimated by the primary efficacy endpoints: worsening of ascites (study 1) and the cumulative number of large-volume paracenteses during 12 weeks (studies 2 and 3). Nevertheless, some of the secondary efficacy endpoints related to the treatment of ascites were met in the three studies, suggesting a slight advantage of satavaptan over placebo in delaying ascites formation. Moreover, satavaptan was more effective than placebo in improving the serum sodium concentration in patients with hyponatraemia. The incidence of major complications of cirrhosis during follow-up did not differ significantly between the satavaptan and placebo groups in the three studies. Overall, the rate of any treatment-related adverse events, serious treatment-related events and treatment-related events leading to permanent discontinuation of treatment did not differ significantly between the treatment groups. However, in study 2 mortality was higher in patients treated with satavaptan compared with placebo (HR 1.47; 95% CI 1.01 to 2.15); no significant differences in mortality between the two groups were observed in the other two studies. No specific cause for the increased mortality was identified. Most deaths were associated with known complications of liver cirrhosis. |
Good |
| 108. Gines P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008;48(1):204-213. |
Experimental-Tx |
110 patients |
To investigate the effects of satavaptan, a highly selective vasopressin V(2) receptor antagonist, on ascites management and serum sodium in hyponatremic patients with cirrhosis. |
A total of 110 patients with cirrhosis, ascites, and hyponatremia (serum sodium < or =130 mmol/L) were included in a multicenter, double-blind, randomized, controlled study comparing three fixed doses of satavaptan (5 mg, 12.5 mg, or 25 mg once daily) versus placebo. Duration of treatment was 14 days and all patients received spironolactone at 100 mg/day. Satavaptan treatment was associated with improved control of ascites, as indicated by a reduction in body weight (mean change at Day 14 was +0.49 kg [+/-4.99] for placebo versus +0.15 kg [+/-4.23], -1.59 kg [+/-4.60] and -1.68 kg [+/-4.98] for the 5 mg, 12.5 mg, and 25 mg doses, respectively; P = 0.05 for a dose-effect relationship overall) and a parallel reduction in abdominal girth. This beneficial effect on ascites was associated with improvements in serum sodium (mean change from baseline to day 5 was 1.3 +/- 4.2, 4.5 +/- 3.5, 4.5 +/- 4.8, and 6.6 +/- 4.3 mmol/L for the placebo group and the groups on satavaptan at 5 mg, 12.5 mg, and 25 mg/day, respectively; P < 0.01 for all compared to placebo). Thirst was significantly more common in patients treated with satavaptan compared to those treated with placebo, whereas the frequency of other adverse events was similar among groups. |
1 |
| 109. Gines P, Wong F, Watson H, et al. Clinical trial: short-term effects of combination of satavaptan, a selective vasopressin V2 receptor antagonist, and diuretics on ascites in patients with cirrhosis without hyponatraemia--a randomized, double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2010;31(8):834-845. |
Experimental-Tx |
110 patients |
To investigate the effects of satavaptan, a highly selective vasopressin V(2) receptor antagonist, on ascites management and serum sodium in hyponatremic patients with cirrhosis. |
Satavaptan treatment was associated with a decrease in ascites (mean change in body weight was -0.36 kg (+/-3.03) for placebo vs. -2.46 kg (+/-3.11), -2.08 kg (+/-4.17) and -2.28 kg (+/-3.24) for the 5 mg, 12.5 mg and 25 mg doses respectively; P = 0.036, P = 0.041 and P = 0.036 for satavaptan 5, 12.5 and 25 mg/day vs. placebo respectively). Thirst and slight increases in serum sodium were more common in patients treated with satavaptan compared with placebo, while other adverse events were similar. |
1 |
| 110. Wong F, Gines P, Watson H, et al. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010;53(2):283-290. |
Experimental-Tx |
151 patients |
To investigate the effects of the addition of a vasopressin V(2) receptor antagonist, satavaptan, to 100mg spironolactone on ascites recurrence after a large volume paracentesis in patients with liver cirrhosis irrespective of the presence of hyponatraemia. |
Median time to first paracentesis was 23, 26, and 17 days with satavaptan 5, 12.5, and 25mg, respectively, versus 14 days with placebo (ns for all doses). The frequency of paracenteses was decreased significantly (p<0.05) in all satavaptan groups versus placebo. Mean increase in ascites was 2.82+/-0.48 L/week for placebo versus 2.12+/-0.40, 2.14+/-0.33, and 2.06+/-0.40 L/week for the 5, 12.5, and 25mg of satavaptan, respectively (ns for all doses). Similar numbers of patients experienced major adverse events in all groups. Increases in serum creatinine, orthostatic changes in systolic pressure and thirst were more common with satavaptan. |
1 |
| 111. Serste T, Melot C, Francoz C, et al. Deleterious effects of beta-blockers on survival in patients with cirrhosis and refractory ascites. Hepatology 2010;52:1017-22. |
Observational-Tx |
151 patients |
To evaluate the effect of the administration of beta-blockers on long-term survival in patients with cirrhosis and refractory ascites. |
The mean Model for End-Stage Liver Disease score was 18.8 6 4.1. All patients regularly underwent large-volume paracentesis and intravenous albumin administration. Seventy-seven patients (51%) were treated with propranolol (113 646 mg/day). The median follow-up for the whole group was 8 months. The median survival time was 10 months [95% confidence interval (CI) 5 8-12 months]. The probability of survival at 1 year was 41% (95% CI 5 33%-49%). The clinical characteristics and laboratory values at enrolment were not significantly different between patients who were receiving propranolol and those who were not. The median survival time was 20.0 months (95% CI 54.8-35.2 months) in patients not treated with propranolol and 5.0 months (95% CI 5 3.5-6.5 months) in those treated with propranolol (P 5 0.0001). The 1-year probability of survival was significantly lower in patients who received propranolol [19% (95% CI 5 9%-29%)] versus those who did not [64%(95%CI552%-76%), P < 0.0001]. The independent variables of mortality were Child-Pugh class C, hyponatremia and renal failure as causes of refractory ascites, and beta-blocker therapy. |
1 |
| 112. Arroyo V, Gines P, Gerbes AL, et al. Definition and diagnostic criteria of refractory ascites and hepatorenal syndrome in cirrhosis. International Ascites Club. Hepatology. 1996;23(1):164-176. |
Review/Other-Tx |
N/A |
No abstract available |
No abstract available |
4 |
| 113. Gines P, Arroyo V, Vargas V, et al. Paracentesis with intravenous infusion of albumin as compared with peritoneovenous shunting in cirrhosis with refractory ascites. N Engl J Med. 1991;325(12):829-835. |
Experimental-Tx |
89 patients |
To study 89 patients with cirrhosis and refractory ascites who were randomly assigned to receive either repeated large-volume paracentesis plus intravenous albumin or a LeVeen peritoneovenous shunt. |
During the first hospitalization, ascites was removed in all 41 patients in the paracentesis group and in 44 of the 48 patients in the peritoneovenous-shunt group. The mean (+/- SD) duration of hospitalization in the two groups was 11 +/- 5 and 19 +/- 9 days, respectively (P less than 0.01). There were no significant differences in the number of patients who had complications or died. During follow-up, 37 patients in each group were hospitalized again. In the paracentesis group, the number of rehospitalizations for any reason (174 vs. 97 in the peritoneovenous-shunt group) or for ascites (125 vs. 38) was significantly higher, and the median time to a first readmission for any reason (1 +/- 1 vs. 2 +/- 2 months) or for ascites (2 +/- 2 vs. 8 +/- 17 months) was significantly shorter than in the peritoneovenous-shunt group. The total times in the hospital during follow-up, however, were similar in the two groups (48 +/- 49 and 44 +/- 39 days, respectively). Three patients had obstructions of their peritoneovenous shunts during their first hospitalizations, and 15 patients had a total of 20 obstructions during follow-up. Survival was similar in both groups. |
1 |
| 114. Moore KP, Wong F, Gines P, et al. The management of ascites in cirrhosis: report on the consensus conference of the International Ascites Club. Hepatology. 2003;38(1):258-266. |
Review/Other-Tx |
N/A |
To discuss the importance of diagnosing noncirrhotic causes of ascites such as malignancy, tuberculosis, and pancreatic ascites, since these occur with increased frequency in patients with liver disease. |
Successful placement of TIPS results in improved renal function, sodium excretion, and general well-being of the patient but without proven survival benefits. Clinicians caring for these patients should be aware of the potential complications of each treatment modality and be prepared to discontinue diuretics or not proceed with TIPS placement should complications or contraindications develop. Liver transplantation should be considered for all ascitic patients, and this should preferably be performed prior to the development of renal dysfunction to prevent further compromise of their prognosis. |
4 |
| 115. Runyon BA. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009;49(6):2087-2107. |
Review/Other-Tx |
N/A |
No abstract available |
No abstract available |
4 |
| 116. Bai M, Qi XS, Yang ZP, Yang M, Fan DM, Han GH. TIPS improves liver transplantation-free survival in cirrhotic patients with refractory ascites: an updated meta-analysis. World J Gastroenterol. 2014;20(10):2704-2714. |
Meta-analysis |
6 studies; 390 patients |
To compare the liver transplantation-free (LTF) survival rates between patients who underwent transjugular intrahepatic portosystemic shunts (TIPS) and those who underwent paracentesis by an updated meta-analysis that pools the effects of both number of deaths and time to death. |
Six randomized controlled trials with 390 patients were included. In comparison to paracentesis, TIPS significantly improved LTF survival (HR = 0.61, 95%CI: 0.46-0.82, P < 0.001). TIPS also significantly decreased liver disease-related death (OR = 0.62, 95%CI: 0.39-0.98, P = 0.04), recurrent ascites (OR = 0.15, 95%CI: 0.09-0.24, P < 0.001) and hepatorenal syndrome (OR = 0.32, 95%CI: 0.12-0.86, P = 0.02). However, TIPS increased the risk of HE (OR = 2.95, 95%CI: 1.87-4.66, P = 0.02) and severe HE (OR = 2.18, 95%CI: 1.27-3.76, P = 0.005). |
M |
| 117. Gines P, Arroyo V, Quintero E, et al. Comparison of paracentesis and diuretics in the treatment of cirrhotics with tense ascites. Results of a randomized study. Gastroenterology. 1987;93(2):234-241. |
Experimental-Tx |
117 patients |
To investigate whether paracentesis could be an alternative therapy for ascites, 117 cirrhotics with tense ascites were randomly allocated into two groups. |
Paracentesis was effective in eliminating the ascites in 56 patients from group 1 (96.5%) and did not induce significant changes in renal and hepatic function, plasma volume, cardiac index, peripheral resistance, plasma renin activity, plasma norepinephrine and antidiuretic hormone concentration, and urinary excretion of prostaglandin E2 and 6-keto-prostaglandin F1 alpha. Diuretics were effective in eliminating the ascites in 43 patients from group 2 (72.8%) (p less than 0.05). Ten patients in group 1 and 36 in group 2 developed complications during their first hospital stay (p less than 0.001). This difference was due to the significantly higher incidence of hepatic encephalopathy, renal impairment, and electrolyte disturbances occurring in patients treated with diuretics. The duration of hospital stay was 11.7 +/- 1.5 days for patients from group 1 and 31 +/- 2.8 days for patients from group 2 (p less than 0.001). The two groups did not differ significantly with respect to the probability of requiring readmission to hospital during follow-up, reasons for readmission, survival probability after entry into the study, and causes of death. |
1 |
| 118. Salerno F, Badalamenti S, Incerti P, et al. Repeated paracentesis and i.v. albumin infusion to treat 'tense' ascites in cirrhotic patients. A safe alternative therapy. J Hepatol. 1987;5(1):102-108. |
Experimental-Tx |
41 patients |
To investigate the usefulness of paracentesis as an alternative treatment for ascites, 41 cirrhotic patients with 'tense' ascites were randomly assigned to treatment with either repeated paracenteses plus i.v. albumin infusion (n = 20) or diuretics (n = 21). |
Satisfactory mobilization of ascites was obtained with paracentesis in all but one case and with diuretics in all but two cases. Ascites disappeared within 3 or 4 days with paracentesis, but only after 15 days with diuretics. The rate of reaccumulation of ascites following paracentesis, without diuretic administration, exceeded 300 g/day in only 5 patients. The incidence of complications and the mortality rate were similar in both groups of patients during hospital stay and during follow-up. |
1 |
| 119. Gines P, Tito L, Arroyo V, et al. Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis. Gastroenterology. 1988;94(6):1493-1502. |
Experimental-Tx |
105 patients |
To investigate whether intravenous albumin infusion is necessary in the treatment of cirrhotics with large-volume paracentesis. |
Paracentesis plus intravenous albumin did not induce significant changes in standard renal function tests, plasma renin activity, and plasma aldosterone. In contrast, paracentesis without albumin was associated with a significant increase in blood urea nitrogen, a marked elevation in plasma renin activity and plasma aldosterone concentration, and a significant reduction in serum sodium concentration. One patient from group 1 and 11 from group 2 developed renal impairment or severe hyponatremia after treatment, or both (chi 2 = 9.19; p less than 0.01). The development of these complications could not be predicted by clinical and laboratory data before treatment. Although the probability of survival after entry into the study was similar in patients from both groups, a multivariate analysis identified the development of hyponatremia or renal impairment, or both, following the first paracentesis treatment and the occurrence of other complications during the first hospitalization (encephalopathy, gastrointestinal bleeding, and severe infection) as being the only independent predictors of mortality. |
1 |
| 120. Pozzi M, Osculati G, Boari G, et al. Time course of circulatory and humoral effects of rapid total paracentesis in cirrhotic patients with tense, refractory ascites. Gastroenterology. 1994;106(3):709-719. |
Experimental-Tx |
12 patients
|
To study tense ascites of cirrhosis that can be treated with total paracentesis. |
Paracentesis (10.7 +/- 4.4 L; 64 +/- 20 minutes) caused marked reduction of intra-abdominal, intrathoracic, right atrial, and pulmonary pressures. Heart rate did not change. Cardiac output and heart volumes increased. Systemic vascular resistances and mean arterial pressure slightly decreased. Baseline plasma renin and aldosterone levels were markedly increased; a reduction was already evident during paracentesis with the lowest values at the end of the procedure. All changes were maintained 24 hours later. Hormones regained baseline levels 6 days later. |
2 |
| 121. Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997;113(2):579-586. |
Experimental-Tx |
37 patients |
To characterize the systemic and hepatic hemodynamic changes associated with paracentesis-induced circulatory dysfunction. |
Paracentesis-induced circulatory dysfunction occurred in 10 patients (renin and norepinephrine increased from 9.0 +/- 10.5 to 28.8 +/- 19.0 ng.mL-1.h-1 and from 752.0 +/- 364.0 to 1223.0 +/- 294.0 pg/mL, respectively) and was associated with significant reduction in systemic vascular resistance (-13.0% +/- 2.6%; P < 0.05) and increase in hepatic venous pressure gradient (from 19.5 +/- 1.5 to 22.5 +/- 2.4 mm Hg; P < 0.01). In the remaining 27 patients, mobilization of ascites also induced a significant but smaller reduction in systemic vascular resistance (-5.0% +/- 1.6%; P < 0.05) without significant changes in renin, norepinephrine, and hepatic venous pressure gradient. |
2 |
| 122. Appenrodt B, Wolf A, Grunhage F, et al. Prevention of paracentesis-induced circulatory dysfunction: midodrine vs albumin. A randomized pilot study. Liver Int. 2008;28(7):1019-1025. |
Experimental-Tx |
24 patients |
To compare the less expensive vasoconstrictor midodrine, an alpha-adrenoceptor agonist, with albumin in preventing PICD. |
PICD developed in six patients of the midodrine group (60%) and in only four patients (31%) of the albumin group. Six days after paracentesis, the aldosterone concentration increased significantly in the midodrine group, but not in the albumin group. |
1 |
| 123. Gines A, Fernandez-Esparrach G, Monescillo A, et al. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996;111(4):1002-1010. |
Experimental-Tx |
289 patients |
To investigate the clinical importance of paracentesis-induced-circulatory dysfunction and compare the efficacy of albumin, dextran 70, and polygeline in preventing this complication. |
Postparacentesis circulatory dysfunction occurred more frequently in patients treated with dextran 70 (34.4%; P = 0.018) or polygeline (37.8%; P = 0.004) than in those receiving albumin (18.5%). The plasma expander used and the volume of ascites removed were independent predictors of this complication. Postparacentesis circulatory dysfunction persisted during follow-up and was associated with a shorter time to first readmission (1.3 +/- 0.5 vs. 3.5 +/- 0.8 months, median +/- SEM; P = 0.03) and shorter survival (9.3 +/- 4.2 vs. 16.9 +/- 4.3 months; P = 0.01). Creatinine and sodium levels in serum, and Child-Pugh score at inclusion, and postparacentesis circulatory dysfunction were independent predictors of survival. |
1 |
| 124. Planas R, Gines P, Arroyo V, et al. Dextran-70 versus albumin as plasma expanders in cirrhotic patients with tense ascites treated with total paracentesis. Results of a randomized study. Gastroenterology. 1990;99(6):1736-1744. |
Experimental-Tx |
88 patients |
To investigate whether albumin can be substituted by less expensive plasma expanders in cirrhotic patients with tense ascites treated with total paracentesis, 88 patients (16 with renal failure) submitted to this therapeutic procedure were randomly assigned to receive IV albumin (43 patients) or dextran-70. |
In patients treated with albumin, no significant changes in renin and aldosterone were observed during the entire period of observation. In contrast, both parameters increased significantly on the 6th day of treatment in patients receiving dextran-70. A significant increase in plasma renin activity and aldosterone concentration (30% over baseline values) was observed in 51% of patients treated with dextran-70 and in only 15% of those treated with albumin (x2 = 10.4; P = 0.0012). |
1 |
| 125. Sola-Vera J, Minana J, Ricart E, et al. Randomized trial comparing albumin and saline in the prevention of paracentesis-induced circulatory dysfunction in cirrhotic patients with ascites. Hepatology. 2003;37(5):1147-1153. |
Experimental-Tx |
72 patients |
To compare the efficacy of saline versus albumin in the prevention of paracentesis-induced circulatory dysfunction (PICD). |
After randomization, 35 patients received saline and 37 received albumin. Twenty-one patients were readmitted for tense ascites and treated with the alternative expander. Significant increases in plasma renin activity (PRA) were found 24 hours and 6 days after paracentesis when saline was used (baseline, 5.6 +/- 5.7; 24 hours, 7.6 +/- 6.9; 6 days, 8.5 +/- 8.0 ng x mL(-1). hr(-1); P <.05 and P <.01 vs. baseline, respectively), whereas no significant changes were observed with albumin. The incidence of PICD was significantly higher in the saline group versus the albumin group (33.3% vs. 11.4%, respectively; P =.03). However, no significant differences were found when less than 6 L of ascitic fluid was evacuated (6.7% vs. 5.6% in the saline and albumin groups, respectively; P =.9). |
1 |
| 126. Moreau R, Valla DC, Durand-Zaleski I, et al. Comparison of outcome in patients with cirrhosis and ascites following treatment with albumin or a synthetic colloid: a randomised controlled pilot trail. Liver Int. 2006;26(1):46-54. |
Experimental-Tx |
68 patients |
To compare outcome and hospital-related cost in patients with cirrhosis treated with 20% human albumin with those treated with a synthetic colloid (3.5% polygeline). |
When the trial was prematurely discontinued because of safety concerns about bovine-derived products, 30 patients were assigned to receive albumin and 38 were assigned to receive a synthetic colloid. Sixty-three patients were included for ascites removal by paracentesis and five patients for ascites removal by paracentesis and renal impairment. The median time to first liver-related complication was not significantly longer in the albumin group (20 vs. 7 days). However, the total number of liver-related complications adjusted to a 100-day period was significantly lower in the albumin group. The median hospital cost for a 30-day period was significantly lower in the albumin group (1915 euros vs. 4612 euros). |
1 |
| 127. Salerno F, Guevara M, Bernardi M, et al. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. Liver Int. 2010;30(7):937-947. |
Review/Other-Tx |
N/A |
To discuss ascites as a frequent complication of cirrhosis and portal hypertension, because of the increase of the sinusoidal hydrostatic pressure. |
Many patients with refractory ascites also have a chronic renal insufficiency that is called hepatorenal syndrome type-2. In these patients ascites may be treated with periodic paracentesis or with transjugular intrahepatic portosystemic shunt. However, only liver transplantation may improve the survival of such patients. |
4 |
| 128. Lata J, Marecek Z, Fejfar T, et al. The efficacy of terlipressin in comparison with albumin in the prevention of circulatory changes after the paracentesis of tense ascites--a randomized multicentric study. Hepatogastroenterology. 2007;54(79):1930-1933. |
Experimental-Tx |
49 patients |
To compare the standard treatment with the administration of a vasoconstrictor terlipressin. |
In any parameter of hemodynamic changes, no statistically significant difference was demonstrated between randomized groups, in particular measurements as well as in the development in the course of the first three days after the intervention. The result suggests similar efficacy of the circulatory dysfunction prevention after the paracentesis in both treatment procedures. In both groups, on the first three days, there was a tendency to improve hemodynamics reflected by the renin-angiotensin-aldosteron system activity. In the terlipressin group, this tendency approached statistically significant levels. |
1 |
| 129. Moreau R, Asselah T, Condat B, et al. Comparison of the effect of terlipressin and albumin on arterial blood volume in patients with cirrhosis and tense ascites treated by paracentesis: a randomised pilot study. Gut. 2002;50(1):90-94. |
Experimental-Tx |
20 patients |
To perform a pilot study comparing the effects of terlipressin and albumin on effective arterial blood volume in patients with cirrhosis treated by paracentesis for tense ascites. |
Irrespective of the treatment group, mean values for plasma renin concentrations at hospital discharge did not differ from their respective baseline values (p=0.10). Baseline plasma levels of renin concentrations did not differ between the terlipressin and albumin groups (p=0.61). Changes from baseline in plasma renin concentrations did not differ between groups (p=0.39). Three patients in the terlipressin group and three in the albumin group developed decreased arterial blood volume. |
1 |
| 130. Singh V, Kumar R, Nain CK, Singh B, Sharma AK. Terlipressin versus albumin in paracentesis-induced circulatory dysfunction in cirrhosis: a randomized study. J Gastroenterol Hepatol. 2006;21(1 Pt 2):303-307. |
Experimental-Tx |
40 patients |
To investigate the preventive effect of terlipressin on paracentesis-induced circulatory dysfunction in patients with cirrhosis after therapeutic paracentesis and compared with that of intravenous albumin. |
Effective arterial blood volumes as indicated by plasma renin activity before and 4-6 days after paracentesis did not differ in the two groups (19.15 +/- 12.1 to 20.33 +/- 12.8 ng/mL per h, P = 0.46 in the albumin group; and 20.11 +/- 10.6 to 21.08 +/- 10.52 ng/mL per h, P = 0.44 in the terlipressin group). Plasma aldosterone concentrations before and 4-6 days after paracentesis were also similar in both groups (1334.75 +/- 1058 to 1440.0 +/- 1161 pg/mL, P = 0.06 in the albumin group; and 1473.0 +/- 1168 to 1572.29 +/- 1182 pg/mL, P = 0.24 in the terlipressin group). Both terlipressin and albumin prevented paracentesis-induced renal impairment in these patients. |
1 |
| 131. Singh V, Dheerendra PC, Singh B, et al. Midodrine versus albumin in the prevention of paracentesis-induced circulatory dysfunction in cirrhotics: a randomized pilot study. Am J Gastroenterol. 2008;103(6):1399-1405. |
Experimental-Tx |
40 patients |
To evaluate midodrine and albumin in the prevention of paracentesis-induced circulatory dysfunction (PICD). |
Plasma renin activity at baseline and at 6 days after paracentesis did not differ in the two groups (43.18 +/- 10.73 to 45.90 +/- 8.59 ng/mL/h, P= 0.273 in the albumin group and 44.44 +/- 8.44 to 41.39 +/- 10.21 ng/mL/h, P= 0.115 in the midodrine group). Two patients had an increase in plasma renin activity of more than 50% from baseline in the albumin group, and none in the midodrine group. A significant increase in 24-h urine volume and urine sodium excretion was noted in the midodrine group. Midodrine therapy was cheaper than albumin therapy. |
1 |
| 132. Lebrec D, Giuily N, Hadengue A, et al. Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial. French Group of Clinicians and a Group of Biologists. J Hepatol. 1996;25(2):135-144. |
Experimental-Tx |
24 patients |
To evaluate transjugular intrahepatic portosystemic shunts procedure for the management of refractory ascites in patients with cirrhosis and to clarify its mechanism of action. |
Shunts were successfully placed in 10 out of 13 patients. At 4 months, ascites had improved in all class B patients in the shunt group and in none of the patients in the paracentesis group (p < 0.05); ascites did not improve in any of the class C patients in either of the groups. At 2 years, the overall survival rate was 29 +/- 13% (mean +/- SE) in the shunt group and 56 +/- 17% in the paracentesis group (p < 0.05). In class B patients, there was no significant difference in mortality. At 4 months, portal pressure was significantly lower than before the shunt, while plasma levels of atrial natriuretic peptide were significantly higher and plasma levels of renin and norepinephrine significantly lower. |
1 |
| 133. Rossle M, Ochs A, Gulberg V, et al. A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites. N Engl J Med. 2000;342(23):1701-1707. |
Experimental-Tx |
60 patients |
To evaluate the benefit of a transjugular intrahepatic portosystemic shunt compared to paracentesis in patients with cirrhosis and ascites. |
Among the patients in the shunt group, 15 died and 1 underwent liver transplantation during the study period, as compared with 23 patients and 2 patients, respectively, in the paracentesis group. The probability of survival without liver transplantation was 69 percent at one year and 58 percent at two years in the shunt group, as compared with 52 percent and 32 percent in the paracentesis group (P=0.11 for the overall comparison, by the log-rank test). In a multivariate analysis, treatment with transjugular shunting was independently associated with survival without the need for transplantation (P=0.02). At three months, 61 percent of the patients in the shunt group and 18 percent of those in the paracentesis group had no ascites (P=0.006). The frequency of hepatic encephalopathy was similar in the two groups. Of the patients assigned to paracentesis in whom this procedure was unsuccessful, 10 received a transjugular shunt a mean of 5.5+/-4 months after randomization; 4 had a response to this rescue treatment. |
1 |
| 134. Sanyal AJ, Genning C, Reddy KR, et al. The North American Study for the Treatment of Refractory Ascites. Gastroenterology. 2003;124(3):634-641. |
Experimental-Tx |
109 patients |
To examine the clinical utility of transjugular intrahepatic portosystemic shunts (TIPS) vis-à-vis total paracentesis in the management of refractory ascites |
A technically adequate shunt was created in 49 of 52 subjects. TIPS plus medical therapy was significantly superior to medical therapy alone in preventing recurrence of ascites (P < 0.001). The total number of deaths in the 2 groups was identical (TIPS vs. medical therapy alone: 21 vs. 21). There were no significant differences in the 2 arms with respect to overall and transplant-free survival. There was a higher incidence of moderate to severe encephalopathy in the TIPS group (20 of 52 vs. 12 of 57; P = 0.058). There were no significant differences in the number of subjects who developed liver failure (7 vs. 3), variceal hemorrhage (5 vs. 8), or acute renal failure (3 vs. 2). There were also no significant differences between the 2 groups in the frequency of emergency-department visits, medically indicated hospitalizations, or quality of life. |
1 |
| 135. Gines P, Uriz J, Calahorra B, et al. Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis. Gastroenterology. 2002;123(6):1839-1847. |
Experimental-Tx |
70 patients |
To study patients with cirrhosis and refractory ascites that were randomly assigned to TIPS (35 patients) or repeated paracentesis plus intravenous albumin (35 patients). |
Twenty patients treated with TIPS and 18 treated with paracentesis died during the study period, whereas 7 patients in each group underwent liver transplantation (mean follow-up 282 +/- 43 vs. 325 +/- 61 days, respectively). The probability of survival without liver transplantation was 41% at 1 year and 26% at 2 years in the TIPS group, as compared with 35% and 30% in the paracentesis group (P = 0.51). In a multivariate analysis, only baseline blood urea nitrogen levels and Child-Pugh score were independently associated with survival. Recurrence of ascites and development of hepatorenal syndrome were lower in the TIPS group compared with the paracentesis group, whereas the frequency of severe hepatic encephalopathy was greater in the TIPS group. The calculated costs were higher in the TIPS group than in the paracentesis group. |
1 |
| 136. Narahara Y, Kanazawa H, Fukuda T, et al. Transjugular intrahepatic portosystemic shunt versus paracentesis plus albumin in patients with refractory ascites who have good hepatic and renal function: a prospective randomized trial. J Gastroenterol. 2011;46(1):78-85. |
Experimental-Tx |
60 patients |
To compare the efficacy of TIPS to that of large-volume paracentesis in cirrhotic patients with refractory ascites who have good hepatic and renal function. |
The baseline characteristics were similar in the two groups. Seventeen patients treated with TIPS and 21 treated with paracentesis died during the study period. The cumulative probabilities of survival at 1 and 2 years were 80 and 64% in the TIPS group and 49 and 35% in the paracentesis group (p < 0.005). TIPS was significantly superior to paracentesis in the control of ascites (p < 0.005). Treatment failure was more frequent in the paracentesis group, whereas the frequency of hepatic encephalopathy was greater in the TIPS group. |
1 |
| 137. Salerno F, Merli M, Riggio O, et al. Randomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites. Hepatology. 2004;40(3):629-635. |
Experimental-Tx |
66 patients |
To study the effect of TIPS on survival as compared with that of large-volume paracentesis plus albumin |
Thirteen patients treated with TIPS and 20 patients treated with paracentesis died during the study period, 4 patients in each group underwent liver transplantation. The probability of survival without transplantation was 77% at 1 year and 59% at 2 years in the TIPS group as compared with 52% and 29% in the paracentesis group (P = .021). In a multivariate analysis, treatment with paracentesis and higher MELD score showed to independently predict death. Treatment failure was more frequent in patients assigned to paracentesis, whereas severe episodes of hepatic encephalopathy occurred more frequently in patients assigned to TIPS. The number and duration of rehospitalizations were similar in the two groups. |
1 |
| 138. Leveen HH, Christoudias G, Ip M, Luft R, Falk G, Grosberg S. Peritoneo-venous shunting for ascites. Ann Surg. 1974;180(4):580-591. |
Review/Other-Tx |
45 patients |
To review case experiences of new minor surgical procedure for ascites has been devised involving a specially designated one way pressure activated valve is implanted to create a permanent peritoneo-venous shunt. |
Prolonged relief of ascites occurred in 28 of 37 cases. |
4 |
| 139. Martin LG. Percutaneous placement and management of the Denver shunt for portal hypertensive ascites. AJR Am J Roentgenol. 2012;199(4):W449-453. |
Review/Other-Tx |
N/A |
To review the development of the peritoneovenous and pleurovenous shunt, discuss reasons for its loss of favor, and suggest its current role in the armamentarium of the interventional radiologist. |
No results stated in abstract |
4 |
| 140. Bratby MJ, Hussain FF, Lopez AJ. Radiological insertion and management of peritoneovenous shunt. Cardiovasc Intervent Radiol. 2007;30(3):415-418. |
Review/Other-Tx |
26 patients |
To report our experience of the management of complications following the insertion of a peritoneovenous shunt for intractable malignant ascites. |
Successful techniques for the restoration of the shunt function include port- pumping, stripping of any fibrin sheath, and revision of either the venous or peritoneal catheter. The procedure was initially successful in all patients with continued patency until death in 17. A further four patients are still alive with a functioning shunt. There was one rapid postprocedure death resulting from pulmonary edema. Two patients developed pneumothorax, managed successfully with either a chest drain or aspiration. Shunt dysfunction occurred eight times in seven patients. There were five successful revisions in four patients. Overall, shunt patency has been maintained in 80.1% of patients. |
4 |
| 141. Foroulis CN, Desimonas NA. Massive pneumoperitoneum: a late complication of the Denver pleuroperitoneal shunt. Ann Thorac Surg. 2005;80(4):e13. |
Review/Other-Tx |
1 patient |
No abstract available |
No abstract available |
4 |
| 142. Lopez-Viego MA, Cornell JM. Pneumoperitoneum and signs of peritonitis from a pleuroperitoneal shunt. Surgery. 1992;111(2):228-229. |
Review/Other-Tx |
1 patient |
To report an unusual complication of a Denver pleuroperitoneal shunt that resulted in pneumoperitoneum and a clinical picture of diffuse peritonitis from a ruptured abdominal viscus. |
The cause of this condition was continuous decompression of a pneumothorax into the peritoneal cavity, through the shunt. |
4 |
| 143. Rosemurgy AS, Zervos EE, Clark WC, et al. TIPS versus peritoneovenous shunt in the treatment of medically intractable ascites: a prospective randomized trial. Ann Surg. 2004;239(6):883-889; discussion 889-891. |
Experimental-Tx |
32 patients |
To undertake a prospective randomized clinical trial comparing TIPS to peritoneovenous (PV) shunts in the treatment of medically intractable ascites to establish relative efficacy and morbidity, and thereby superiority, between these shunts. |
After TIPS versus peritoneovenous shunts, median (mean +/- SD) duration of shunt patency was similar: 4.4 months (6 +/- 6.6 months) versus 4.0 months (5 +/- 4.6 months). Assisted shunt patency was longer after TIPS: 31.1 months (41 +/- 25.9 months) versus 13.1 months (19 +/- 17.3 months) (P < 0.01, Wilcoxon test). Ultimately, after TIPS 19% of patients had irreversible shunt occlusion versus 38% of patients after peritoneovenous shunts. Survival after TIPS was 28.7 months (41 +/- 28.7 months) versus 16.1 months (28 +/- 29.7 months) after peritoneovenous shunts. Control of ascites was achieved sooner after peritoneovenous shunts than after TIPS (73% vs. 46% after 1 month), but longer-term efficacy favored TIPS (eg, 85% vs. 40% at 3 years). |
1 |
| 144. Zervos EE, Rosemurgy AS. Management of medically refractory ascites. Am J Surg. 2001;181(3):256-264. |
Review/Other-Tx |
N/A |
To review the current therapeutic options for medically refractory ascites focusing on indications, benefits, and drawbacks of each specific therapy. |
No results stated in abstract |
4 |
| 145. Boyer TD, Sanyal AJ, Wong F, et al. Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1. Gastroenterology 2016;150:1579-89 e2. |
Experimental-Tx |
196 patients (97 patients in experimental group; 99 patients in control group) |
To evaluate the efficacy and safety of intravenous terlipressin plus albumin vs placebo plus albumin in patients with hepatorenal syndome type 1 (HRS-1). |
Baseline demographic/clinical characteristics were similar between groups. CHRSR was observed in 19 of 97 patients (19.6%) receiving terlipressin vs 13 of 99 patients (13.1%) receiving placebo (P = .22). HRS reversal was achieved in 23 of 97 (23.7%) patients receiving terlipressin vs 15 of 99 (15.2%) receiving placebo (P = .13). SCr decreased by 1.1 mg/dL in patients receiving terlipressin and by only 0.6 mg/dL in patients receiving placebo (P < .001). Decreases in SCr and survival were correlated (r2) = .882; P < .001). Transplant-free and overall survival were similar between groups. A significantly greater proportion of patients with CHRSR who received terlipressin survived until day 90 than patients who did not have CHRSR after receiving terlipressin (P < .001); this difference was not observed in patients who did vs did not have CHRSR after receiving placebo (P = .28). There were similar numbers of adverse events in each group, but patients in the terlipressin group had more ischemic events. |
1 |
| 146. Gifford FJ, Morling JR, Fallowfield JA. Systematic review with meta-analysis: vasoactive drugs for the treatment of hepatorenal syndrome type 1. Aliment Pharmacol Ther 2017;45:593-603. |
Meta-analysis |
12 trials, 700 patients |
To re-evaluate efficacy and safety of pharmacological treatments for HRS1, in the light of recently published randomised controlled trials (RCTs). |
Twelve RCTs enrolling 700 HRS1 patients were included. Treatment with terlipressin and albumin led to HRS1 reversal more frequently than albumin alone or placebo (RR: 2.54, 95% CI: 1.51–4.26). Noradrenaline was effective in reversing HRS1, but trials were small and nonblinded. Overall, there was mortality benefit with terlipressin (RR: 0.79, 95% CI: 0.63–1.01), but sensitivity analysis including only trials with low risk of selection bias weakened this relationship (RR: 0.87, 95% CI: 0.71–1.06). Notably, there was a significant risk of adverse events with terlipressin therapy (RR: 4.32, 95% CI: 0.75–24.86). |
Good |
| 147. Amin AA, Alabsawy EI, Jalan R, Davenport A. Epidemiology, Pathophysiology, and Management of Hepatorenal Syndrome. Semin Nephrol 2019;39:17-30. |
Review/Other-Tx |
N/A |
To discuss the current and recent data about classification, pathophysiology, and management of AKI in general, with specific insight about the treatment of HRS AKI. |
Not included in abstract. |
4 |
| 148. European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol 2010;53:397-417. |
Review/Other-Dx |
N/A |
To provide guidance on the management of ascites in patients with cirrhosis. |
No results stated in abstract. |
4 |
| 149. Runyon BA, Aasld. Introduction to the revised American Association for the Study of Liver Diseases Practice Guideline management of adult patients with ascites due to cirrhosis 2012. Hepatology 2013;57:1651-3. |
Review/Other-Dx |
N/A |
To provide guidance on treatment options and management of ascites in adult patients due to cirrhosis. |
No results stated in abstract. |
4 |
| 150. Colle I, Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Rev Gastroenterol Hepatol 2018;12:173-88. |
Review/Other-Tx |
N/A |
To discuss the use of vasoconstrictors in hepatorenal syndrome (HRS). |
Not included in abstract. |
4 |
| 151. Cavallin M, Kamath PS, Merli M, et al. Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial. Hepatology 2015;62:567-74. |
Experimental-Tx |
27 patients |
To compare the effectiveness of terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of HRS in a randomized controlled trial. |
There was a significantly higher rate of recovery of renal function in the TERLI group (19/27, 70.4%) compared to the MID/OCT group (6/21, 28.6%), P = 0.01. Improvement in renal function and lower baseline Model for End-Stage Liver Disease score were associated with better survival. |
1 |
| 152. Sharma P, Kumar A, Shrama BC, Sarin SK. An open label, pilot, randomized controlled trial of noradrenaline versus terlipressin in the treatment of type 1 hepatorenal syndrome and predictors of response. Am J Gastroenterol 2008;103:1689-97. |
Observational-Tx |
40 patients |
To compare the efficacy of terlipressin and noradrenaline on the renal functions and clinical outcome of patients with HRS-1 and also seek predictors of response. |
The two groups were comparable at baseline. At similar time points, 10 (50%) patients in each group achieved primary end points. Patients in both groups had a significant (P < 0.05) decrease in serum creatinine from baseline (group A day 4 2.4 +/- 1.2 mg/dL, day 8 1.6 +/- 1.2 mg/dL, and day 15 1.0 +/- 0.4 mg/dL; group B day 4 2.5 +/- 1.5 mg/dL, day 8 1.8 +/- 0.9 mg/dL, and day 15 1.2 +/- 0.5 mg/dL) and progressive increase in creatinine clearance (group A day 4 26.5 +/- 12.8 mL/min and day 15 59.8 +/- 14.2 mL/min; group B day 4 31.4 +/- 21.4 mL/min and day 15 54.9 +/- 27.5 mL/min, P < 0.05). Median baseline plasma renin activity was reduced from 38.0 and 42.0 ng/mL/h to 3.0 and 8.0 ng/mL/h (P= 0.08) in groups A and B, respectively. Mean arterial BP and urine output significantly increased in both groups with therapy. Eleven (55%) patients in group A (10 responders) and an equal number in group B (8 responders) survived until day 15 (P= 0.798). Reversible cardiac ischemia was seen in one patient in each group. Noradrenaline therapy was significantly less expensive than terlipressin. On univariate analysis, the following baseline parameters predicted response to therapy: lower grade of encephalopathy, lower MELD score, higher creatinine clearance, higher mean arterial pressure (MAP), and lower plasma renin activity. However, on multivariate analysis only baseline creatinine clearance, MAP, and plasma renin activity were independent predictors of response. At day 4 of therapy, DCD4 was computed and a value of 0.15 mg/dL/day or more accurately predicted response. The sensitivity, specificity, positive predictive value, and negative predictive value for DCD4 0.15 mg/dL/day for predicting response to therapy were 90%, 75%, 78%, and 88%, respectively. |
2 |
| 153. Ghosh S, Choudhary NS, Sharma AK, et al. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. Liver Int 2013;33:1187-93. |
Observational-Tx |
46 patients |
To evaluate the safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 hepatorenal syndrome (HRS). |
HRS reversal could be achieved in 17(73.9%) patients in group A as well as in group B (P = 1.0). Univariate analysis showed that the baseline model of end-stage liver disease score, urine output, urinary sodium, serum creatinine and mean arterial pressure were associated with response. However, in multivariate analysis only baseline serum creatinine, urine output and urinary sodium were associated with the response. Eight patients in group A and 9 in group B died within 90 days of follow-up (P > 0.05). Noradrenaline was less expensive than terlipressin (P < 0.05). No major adverse effects were seen. |
1 |
| 154. Sanyal AJ, Boyer TD, Frederick RT, et al. Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies. Aliment Pharmacol Ther 2017;45:1390-402. |
Meta-analysis |
308 patients; 2 studies |
To compare the efficacy of terlipressin plus albumin vs. placebo plus albumin in patients with HRS-1. |
The pooled analysis comprised 308 patients (terlipressin: n = 153; placebo: n = 155). HRS reversal was significantly more frequent with terlipressin vs. placebo (27% vs. 14%; P = 0.004). Terlipressin was associated with a more significant improvement in renal function from baseline until end of treatment, with a mean between-group difference in SCr concentration of -53.0 µmol/L (P < 0.0001). Lower SCr, lower mean arterial pressure and lower total bilirubin and absence of known precipitating factors for HRS were independent predictors of HRS reversal and longer survival in terlipressin-treated patients. |
Inadequate |
| 155. Boyer TD, Sanyal AJ, Garcia-Tsao G, et al. Predictors of response to terlipressin plus albumin in hepatorenal syndrome (HRS) type 1: relationship of serum creatinine to hemodynamics. J Hepatol 2011;55:315-21. |
Experimental-Tx |
35 patients |
To understand how terlipressin reverses renal failure in patients with type 1 hepatorenal syndrome (HRS). |
Single variant analysis showed treatment with terlipressin, MELD score, and baseline serum creatinine to be predictive of HRS reversal. Alcoholic hepatitis, baseline serum creatinine, and MELD score were predictive of survival. When treatment was not considered as a variable, only baseline serum creatinine predicted HRS reversal. Baseline serum creatinine, presence of alcoholic hepatitis, and Child-Pugh score were also predictive of survival on multivariate analysis. The rise in mean arterial pressure (MAP) following terlipressin administration was not predictive of HRS reversal. However, in those who achieved HRS reversal from terlipressin, there was a significant rise in MAP from beginning to end of treatment. |
1 |
| 156. Sanyal AJ, Boyer T, Garcia-Tsao G, et al. A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology 2008;134:1360-8. |
Experimental-Tx |
56 patients |
To evaluate the efficacy and safety of terlipressin, a systemic arterial vasoconstrictor, for cirrhosis type 1 HRS. |
Fifty-six subjects were randomized to each arm. Treatment success with terlipressin was double that with placebo (25% vs 12.5%, P = .093). SCr level improved from baseline to day 14 on terlipressin (-0.7 mg/dL) as compared with placebo (0 mg/dL), P < .009. Terlipressin was superior to placebo for HRS reversal (34% vs 13%, P = .008), defined by decrease in SCr level </=1.5 mg/dL. Overall and transplantation-free survival was similar between study groups; HRS reversal significantly improved survival at day 180. One nonfatal myocardial infarction occurred with terlipressin, but the total adverse event rate was similar to placebo. |
1 |
| 157. Neri S, Pulvirenti D, Malaguarnera M, et al. Terlipressin and albumin in patients with cirrhosis and type I hepatorenal syndrome. Dig Dis Sci 2008;53:830-5. |
Meta-analysis |
574 patients; 19 studies |
To determine the impact of albumin dose on treatment outcomes. |
Nineteen clinical studies with 574 total patients were included, comprising 8 randomized controlled trials, 8 prospective studies and 3 retrospective studies. The pooled percentage of patients achieving hepatorenal syndrome reversal was 49.5% (95% confidence interval, 40.0-59.1%). Increments of 100 g in cumulative albumin dose were accompanied by significantly increased survival (hazard ratio, 1.15; 95% confidence interval, 1.02-1.31; p = 0.023). A non-significant increase of similar magnitude in hepatorenal syndrome reversal was also observed (odds ratio, 1.15; 95% confidence interval, 0.97-1.37; p = 0.10). Expected survival rates at 30 days among patients receiving cumulative albumin doses of 200, 400 and 600 g were 43.2% (95% confidence interval, 36.4-51.3%), 51.4% (95% confidence interval, 46.3-57.1%) and 59.0% (95% confidence interval, 51.9-67.2), respectively. Neither survival nor hepatorenal syndrome reversal was significantly affected by vasoconstrictor dose or type, treatment duration, age, baseline serum creatinine, bilirubin or albumin, baseline mean arterial pressure, or study design, size or time period. |
Good |
| 158. Solanki P, Chawla A, Garg R, Gupta R, Jain M, Sarin SK. Beneficial effects of terlipressin in hepatorenal syndrome: a prospective, randomized placebo-controlled clinical trial. J Gastroenterol Hepatol 2003;18:152-6. |
Observational-Tx |
24 patients |
To examine the effects of terlipressin on renal function, systemic hemodynamics and clinical outcome in patients with HRS. |
The two groups were comparable at baseline. After treatment with terlipressin, urine output significantly (P < 0.05) increased progressively in group A (day 4, 960 +/- 40 mL/24 h; day 8, 1068 +/- 56 mL/24 h) compared with group B (day 4, 451 +/- 40 mL/24 h; day 8, 291 +/- 45 mL/24 h). Creatinine clearance improved (P < 0.05) in group A (day 4, 20.2 +/- 2.1 mL/min; day 8, 35 +/- 2.8 mL/min) compared with group B (day 4, 11.3 +/- 1.3 mL/min; day 8, 9.3 +/- 1.7 mL/min). Serum creatinine decreased in group A but not in group B (day 8, 1.6 +/- 0.01 compared with 3.9 +/- 0.26, P < 0.05). Mean arterial pressure increased significantly (P < 0.05) in group A. Terlipressin administration was associated with transient self-limiting side-effects including crampy abdominal pain in two patients and cardiac arrhythmias in three patients. Five of the 12 patients survived in group A compared with none in group B at day 15 (P < 0.05) and all survivors had reversal of HRS. |
1 |
| 159. Sridharan K, Sivaramakrishnan G. Vasoactive Agents for Hepatorenal Syndrome: A Mixed Treatment Comparison Network Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials. J Gen Intern Med 2018;33:97-102. |
Meta-analysis |
16 studies |
To conduct a network meta-analysis to compare the interventions used for treating h epatorenal syndrome (HRS), with complete HRS reversal as the primary outcome measure. |
A total of 16 studies were included in the systematic review. Rates of complete HRS reversal were significantly higher with terlipressin and noradrenaline combined with albumin than with placebo (OR 6.65, 95% CI: 2.08-21.31 and 6.81, 95% CI: 1.87-24.83, respectively). No significant differences were observed in terms of mortality, partial HRS reversal, or adverse events for any of the interventions. However, cardiovascular adverse events were significantly higher with continuous-infusion terlipressin/albumin (OR 7.07, 95% CI: 1.23-40.62), bolus terlipressin/albumin (OR 7.39, 95% CI: 1.89, 28.94), octreotide/midodrine/albumin (OR 9.85, 95% CI: 1.1, 88.1), and noradrenaline/albumin (OR 15.24, 95% CI: 2.1, 112.6) than with albumin alone. Trial sequential analyses revealed adequate evidence to conclude that terlipressin combined with albumin was effective in achieving complete HRS reversal. |
Not Assessed |
| 160. Salerno F, Navickis RJ, Wilkes MM. Albumin treatment regimen for type 1 hepatorenal syndrome: a dose-response meta-analysis. BMC Gastroenterol 2015;15:167. |
Meta-analysis |
574 patients; 19 studies |
To determine the impact of albumin dose on treatment outcomes. |
Nineteen clinical studies with 574 total patients were included, comprising 8 randomized controlled trials, 8 prospective studies and 3 retrospective studies. The pooled percentage of patients achieving hepatorenal syndrome reversal was 49.5% (95% confidence interval, 40.0-59.1%). Increments of 100 g in cumulative albumin dose were accompanied by significantly increased survival (hazard ratio, 1.15; 95% confidence interval, 1.02-1.31; p = 0.023). A non-significant increase of similar magnitude in hepatorenal syndrome reversal was also observed (odds ratio, 1.15; 95% confidence interval, 0.97-1.37; p = 0.10). Expected survival rates at 30 days among patients receiving cumulative albumin doses of 200, 400 and 600 g were 43.2% (95% confidence interval, 36.4-51.3%), 51.4% (95% confidence interval, 46.3-57.1%) and 59.0% (95% confidence interval, 51.9-67.2), respectively. Neither survival nor hepatorenal syndrome reversal was significantly affected by vasoconstrictor dose or type, treatment duration, age, baseline serum creatinine, bilirubin or albumin, baseline mean arterial pressure, or study design, size or time period. |
Good |
| 161. Brensing KA, Textor J, Perz J, et al. Long term outcome after transjugular intrahepatic portosystemic stent-shunt in non-transplant cirrhotics with hepatorenal syndrome: a phase II study. Gut. 2000;47(2):288-295. |
Experimental-Tx |
41 patients |
To study the feasibility, safety, and long term survival after transjugular intrahepatic portosystemic stent-shunt (TIPS) in 41 non-transplantable cirrhotics with (hepatorenal syndrome) HRS. |
TIPS markedly reduced the portal pressure gradient (21 (5) to 13 (4) mm Hg (mean (SD)); p<0.001) with one procedure related death (3.2%). Renal function deteriorated without TIPS but improved (p<0.001) within two weeks after TIPS (creatinine clearance 18 (15) to 48 (42) ml/min; sodium excretion 9 (16) to 77 (78) mmol/24 hours) and stabilised thereafter. Following TIPS, three, six, 12, and 18 month survival rates were 81%, 71%, 48%, and 35%, respectively. As only 10% of non-shunted patients survived three months, total survival rates were 63%, 56%, 39%, and 29%, respectively. Multivariate Cox regression analysis revealed bilirubin (p<0.001) and HRS type (p<0.05) as independent survival predictors after TIPS. |
1 |
| 162. Guevara M, Gines P, Bandi JC, et al. Transjugular intrahepatic portosystemic shunt in hepatorenal syndrome: effects on renal function and vasoactive systems. Hepatology. 1998;28(2):416-422. |
Experimental-Tx |
7 patients |
To prospectively evaluate the effects of Transjugular intrahepatic portosystemic shunt (TIPS) on renal function and vasoactive systems in patients with type I (hepatorenal syndrome) HRS. |
Serum creatinine and blood urea nitrogen (BUN) decreased from 5 +/- 0.8 and 109 +/- 7 to 1.8 +/- 0.4 mg/dL and 56 +/- 11 mg/dL, respectively (P < .05 for both), and GFR and RPF increased from 9 +/- 4 and 103 +/- 33 to 27 +/- 7 mL/min and 233 +/- 40 mL/min, respectively (P < .05 for both), 30 days after TIPS. These beneficial effects on renal function were associated with a significant (P < .05) reduction of PRA (18 +/- 5 to 3 +/- 1 ng/mL x h), ALDO (279 +/- 58 to 99 +/- 56 ng/dL), and NE (1,257 +/- 187 to 612 +/- 197 pg/mL). ET did not change significantly (28 +/- 8 to 27 +/- 11 pg/mL). Mean survival was 4.7 +/- 2 months (0.3-17 months). Three patients remained alive more than 3 months after TIPS insertion. |
2 |
| 163. Lake JR, Ring E, LaBerge J, Gordon R, Roberts J, Ascher N. Transjugular intrahepatic portacaval stent shunts in patients with renal insufficiency. Transplant Proc. 1993;25(2):1766-1767. |
Observational-Tx |
8 patients |
To determine the effect of transjugular intrahepatic portosystemic shunt (TIPS) on renal function in patients with cirrhosis and renal insufficiency undergoing TIPS. |
Of the eight patients studied, five showed an improvement in serum creatinine which persisted greater than 7 days. The mean fall in serum creatinine in these 5 patients was 1.4 mg%. |
3 |
| 164. Testino G, Ferro C, Sumberaz A, et al. Type-2 hepatorenal syndrome and refractory ascites: role of transjugular intrahepatic portosystemic stent-shunt in eighteen patients with advanced cirrhosis awaiting orthotopic liver transplantation. Hepatogastroenterology. 2003;50(54):1753-1755. |
Experimental-Tx |
18 patients |
To consider eighteen consecutive patients affected by advanced cirrhosis (Child-Pugh 10-12) awaiting orthotopic liver transplantation and suitable for TIPS treatment for the presence of type-2 hepatorenal syndrome. |
The stent shunt was successfully established in all eighteen patients. Complications occurred in 4 patients (temperature above 38 degrees C or vomiting). No patients have developed hepatic encephalopathy resistant to medical treatment. As for the ascites a complete response with total remission of ascites was obtained in eight patients, while a partial response with the presence of sonographically detectable ascites, without the need of paracentesis, was obtained in ten patients. As regards renal functional parameters we have evidenced a significant improvement after TIPS. |
2 |
| 165. Wong F, Pantea L, Sniderman K. Midodrine, octreotide, albumin, and TIPS in selected patients with cirrhosis and type 1 hepatorenal syndrome. Hepatology. 2004;40(1):55-64. |
Experimental-Tx |
14 patients |
To determine the efficacy of transjugular intrahepatic portosystemic stent shunt (TIPS) as a treatment for type 1 hepatorenal syndrome (HRS) in ascitic cirrhotic patients, following improvement in systemic hemodynamics with a combination of midodrine, octreotide, and albumin (medical treatment). |
Medical therapy for 14 +/- 3 days improved renal function (serum creatinine: 233 +/- 29 micromol/L vs. 112 +/- 8 micromol/L, P =.001) and renal sodium excretion (5 +/- 2 mmol/d vs. 9 +/- 2 mmol/d, P =.002) in 10 of the 14 patients. TIPS insertion in five of the responders further improved renal function and sodium excretion, so that by 12 months post-TIPS, glomerular filtration rate (96 +/- 20 mL/min, P <.01 vs. pre-TIPS) and urinary sodium excretion (119 +/- 15 mmol/d, P <.01 vs. pre-TIPS) were normal, associated with normalization of plasma renin and aldosterone levels and elimination of ascites. |
2 |
| 166. Linas SL, Schaefer JW, Moore EE, Good JT, Jr., Giansiracusa R. Peritoneovenous shunt in the management of the hepatorenal syndrome. Kidney Int 1986;30:736-40. |
Observational-Tx |
29 patients |
To determine the clinical efficacy of the peritoneovenous (PV) shunt in a prospective study of patients with well-defined hepatorenal syndrome (HRS). |
We prospectively compared the PV shunt (N = 10) to Medical Therapy (MED) (N = 10) on renal function and mortality in 20 patients with the HRS associated with alcoholic liver disease. The HRS was diagnosed on the basis of clinical, hemodynamic, and laboratory criteria. The insertion of a PV shunt resulted in an increase in pulmonary capillary wedge pressure (4.2± 1.1 vs. -1.5±1.0mm Hg, P < 0.01) and in cardiac index (0.8 ± 0.3 vs. -0.2 ± 0.3 1/minIm2, P < 0.05). After 48 to 72 hours, weight (± 3.1 ± 1.1 kg) and serum creatinine (3.9 ± 0.5 to 5.5 ± 0.7 mg/dl, P < 0.001) were increased with MED therapy and decreased (weight: -3.7 ± 0.7 kg; serum creatinine: 3.6 ± 0.4 to 3.0 ± 0.5, P < 0.05) with the PV shunt. Despite improvement in renal function, only one patient with the PV shunt had prolonged survival (210 days). In the remainder, survival was 13.8 ± 2.2 days compared to 4.1 ± 0.6 days with MED therapy. |
1 |
