Reference
Reference
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Study Type
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Patients/Events
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Study Objective(Purpose of Study)
Study Results
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1. Hortobagyi GN. Treatment of breast cancer. N Engl J Med. 1998;339(14):974-984. Review/Other-Tx N/A No objective stated in abstract. No results stated in abstract. 4
2. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998;352(9138):1407-1412. Experimental-Tx 267 patients To compare survival between irinotecan and the most widely used treatments of fluorouracil given by continuous infusion in patients with advanced colorectal cancer after failure of first-line fluorouracil. 133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0·035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10·8 months in the irinotecan group and 8·5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4·2 vs 2·9 months for irinotecan vs fluorouracil, respectively; p=0·030). The median pain-free survival was 10·3 months and 8·5 months (p=0·06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups. 1
3. American College of Radiology. ACR Appropriateness Criteria®: Jaundice. Available at: https://acsearch.acr.org/docs/69497/Narrative/. 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 a specific clinical condition. No results stated in abstract. 4
4. Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012;6(2):172-187. Review/Other-Tx N/A To discuss ultrasonography as an ideal means to quantitate the frequency of gallstone disease, being a noninvasive and safe imaging technique that accurately can detect the point prevalence of gallstones in a defined asymptomatic population. Gallbladder cancer is uncommon in developed countries. In the U.S., it accounts for only ~ 5,000 cases per year. Elsewhere, high incidence rates occur in North and South American Indians. Other than ethnicity and female gender, additional risk factors for gallbladder cancer include cholelithiasis, advancing age, chronic inflammatory conditions affecting the gallbladder, congenital biliary abnormalities, and diagnostic confusion over gallbladder polyps. 4
5. Huang RJ, Thosani NC, Barakat MT, et al. Evolution in the utilization of biliary interventions in the United States: results of a nationwide longitudinal study from 1998 to 2013. Gastrointest Endosc. 2017;86(2):319-326 e315. Review/Other-Tx N/A To describe trends in bile duct surgery (BDS), percutaneous transhepatic cholangiography (PTC), and Endoscopic Retrograde Cholangiopancreatography (ERCP) interventions used to treat biliary disease. Total biliary interventions decreased over the study period from 119.8 to 100.1 per 100,000. Diagnostic ERCP utilization decreased by 76%, and therapeutic ERCP utilization increased by 35%. BDS rates decreased by 78% and PTC rates by 24%. ERCP has almost completely supplanted surgery for the management of choledocholithiasis. Fatality from ERCP, BDS, and PTC have all decreased, whereas mean length of stay has remained stable. The proportion of Medicare-insured, Medicaid-insured, and uninsured patients undergoing biliary procedures has increased over time. Most of the increase in therapeutic ERCP and decrease in BDS occurred in large, metropolitan hospitals. 4
6. Bodger K, Bowering K, Sarkar S, Thompson E, Pearson MG. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc. 2011;74(4):825-833. Observational-Dx 20,246 (2006-2007), 20,692(2007-2008) patients. To develop methods for analyzing administrative data for English hospitals with linkage to death registration to study all-cause mortality after first Endoscopic retrograde cholangiopancreatography (ERCP) and explore predictors of death and institutional variation. We analyzed 20,246 first ERCPs from 2006 to 2007 and 20,422 from 2007 to 2008. Diagnostic profile: gallstone related 57.3%; cancer 12.6%; gallstone and cancer 2%; others 28.1%. All-cause 30-day death was 5.3% (2.4% in non-cancer cases). Predictors of 30-day death (adjusted odds ratio [OR]) were as follows: age (OR 6.2, for >/=85 years vs <55 years), male sex (OR 1.2 vs female), emergency admission (OR 2.0 vs elective), cancer (OR 8.6 vs no cancer), and non-cancer comorbidity (OR 1.5 vs none). A mortality risk estimator (look-up table) based on pooled data for >40,000 first ERCPs is provided. Specific procedural complication codes were identified in 1.2% of deaths (0.06% of ERCPs). At the institutional level, analysis of mortality rates was within expected statistical funnel limits, and we found no correlation with ERCP volume (Pearson r = -0.05; P > .05). 3
7. Cerefice M, Sauer B, Javaid M, et al. Complex biliary stones: treatment with removable self-expandable metal stents: a new approach (with videos). Gastrointest Endosc. 2011;74(3):520-526. Experimental-Tx 36 patients To evaluate the efficacy and safety of covered self-expandable metal stents (CSEMSs) in patients with retained complex biliary stones. CSEMS placement was successful in establishing immediate biliary drainage in all 36 patients. Complete duct clearance at repeat ERC was achieved in 29 of 35 patients after a mean duration of 6.4 weeks. Four of the remaining 6 patients underwent sequential CSEMS placement, with eventual duct clearance after multiple ERCPs. There were no complications related to biliary obstruction. One patient died of a nonbiliary cause. Of the total 42 CSEMSs placed, there were 4 cases (9.5%) of clinically insignificant stent migration. 3
8. Vaira D, D'Anna L, Ainley C, et al. Endoscopic sphincterotomy in 1000 consecutive patients. Lancet. 1989;2(8660):431-434. Observational-Tx 1000 patients To describe the results of endoscopic sphincterotomy in a series of 1000 consecutive patients. Endoscopic cholangiography was successful in 985 patients, of whom 782 had visible stones and 203 had a dilated bileduct but no visible stones. Endoscopic sphincterotomy was successful in 975 of these patients, with eventual bileduct clearance in 674 of 772 patients (87.3%) with visible stones; immediate bileduct drainage was achieved in 160 of the 161 patients (99%) in whom bileduct clearance failed at the first attempt. Overall, 771 of 797 patients (96.7%) with visible bileduct stones had successful bileduct clearance or drainage. Complications occurred in 6.9%, with a 30-day mortality rate of 1.2%, but procedure-related mortality was only 0.6%. 2
9. Copelan A, Kapoor BS. Choledocholithiasis: Diagnosis and Management. Tech Vasc Interv Radiol. 2015;18(4):244-255. Review/Other-Tx N/A To review clinical presentations,imaging modalities,and different management options,particularly percutaneous techniques for the management of choledocholithiasis or hepatolithiasis. No results stated in abstract. 4
10. Chopra KB, Peters RA, O'Toole PA, et al. Randomised study of endoscopic biliary endoprosthesis versus duct clearance for bileduct stones in high-risk patients. Lancet. 1996;348(9030):791-793. Experimental-Tx 86 patients To compare the results of endoprosthesis insertion and endoscopic duct clearance in patients with symptomatic bileduct stone who were at high risk because of old age(>70 yr) or serious debilitating disease. In the BE group biliary drainage was achieved in the first session in all but one patient (who required 2 sessions). In the DC group, 24 patients had duct clearance at the first attempt and 35 (81%) after a median of 2 sessions (range 2–4); eight of this group had an endoprosthesis inserted to maintain long-term drainage. At 72 h the complication rates were 7% in the BE group and 16% in the DC group (p=0·18). However, the long-term complication rate for BE was higher: by Kaplan-Meier analysis, at a median of 20 months the proportions free of biliary complications were 64% BE and 86% DC (p=0·03, log-rank test). 2
11. Bakhru MR, Kahaleh M. Expandable metal stents for benign biliary disease. Gastrointest Endosc Clin N Am. 2011;21(3):447-462, viii. Review/Other-Tx N/A To review currently published experience on SEMS and attempts to define their current role in the treatment of benign biliary diseases. No results stated in abstract. 4
12. Ge N, Wang S, Wang G, et al. Endoscopic ultrasound-assisted cholecystogastrostomy by a novel fully covered metal stent for the treatment of gallbladder stones. Endosc Ultrasound. 2015;4(2):152-155. Review/Other-Tx 1 patient To provide a report about a patient with symptomatic gallstones who underwent endoscopic transgastric cholecystolithotomy via a fistula formed around a lumen-apposing metal stent that had been deployed during a previous cholecystogastrostomy procedure. Two weeks after the procedure, the fistulas had formed, and the stent were removed. Endoscopic cholecystolithotomy was successfully performed through the fistula. The ultrasound exam of gallbladder 4 weeks later showed no stone remain and satisfactory function. 4
13. Hintze RE, Veltzke W, Adler A, Abou-Rebyeh H. Endoscopic sphincterotomy using an S-shaped sphincterotome in patients with a Billroth II or Roux-en-Y gastrojejunostomy. Endoscopy. 1997;29(2):74-78. Review/Other-Tx 65 patients To describe a new procedure facilitating endoscopic retrograde cholangiopancreatography (ERCP) in patients who have undergone gastrojejunostomy. We were able to advance the conventional side-viewing endoscope into the duodenal stump in 92% of the patients (n = 59) with Billroth II gastrojejunostomies, and in 33% of the patients (n = 6) with Roux-en-Y anastomoses. Whenever it was possible to reach the duodenal stump, cannulation and sphincterotomy of the papilla of Vater was successful. Ninety-six percent of the patients who underwent sphincterotomy (n = 54) immediately benefited from biliary decompression. One major complication occurred, with a patient suffering a retroperitoneal perforation during endoscopic sphincterotomy; the patient later died, despite three subsequent surgical operations. 4
14. Wright BE, Cass OW, Freeman ML. ERCP in patients with long-limb Roux-en-Y gastrojejunostomy and intact papilla. Gastrointest Endosc. 2002;56(2):225-232. Review/Other-Tx 15 patients To review all ERCP procedures attempted over a 6-year interval in patients with Roux-en-Y gastrojejunostomies and an intact papilla. Of 15 patients in whom ERCP was attempted, the papilla was reached in 10 patients (67%), the bile duct being accessed in all 10. Needle-knife precut papillotomy after placement of a pancreatic duct stent was performed in 3 patients. Biliary sphincterotomy with a variety of techniques was successful in all 9 patients in whom it was attempted. Other maneuvers included stone extraction, sphincter of Oddi manometry, and biliary stent placement. Final diagnoses were sphincter of Oddi dysfunction (6), malignant biliary stricture (2), choledocholithiasis plus tumor (1), and choledocholithiasis (1). Complications occurred after 3 (12%) of 25 ERCP procedures including pancreatitis (1 mild, 1 moderate) and bleeding (1 mild), all in patients with sphincter of Oddi dysfunction. 4
15. Siddiqui AA, Mehendiratta V, Loren D, et al. Self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline-resectable pancreatic cancer: outcomes in 241 patients. Dig Dis Sci. 2013;58(6):1744-1750. Review/Other-Tx 241 patients. To report our experience in using self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline resectable carcinoma of the pancreatic head. Two-hundred and forty-one patients were evaluated [123 male, mean age (+/- SD) 67.4 +/- 9.8 years; resectable 174, borderline resectable 67]. Patients with borderline-resectable cancer underwent neoadjuvant therapy and restaging before possible curative surgery. Successful placement of a metal biliary stent was achieved in all patients and improved jaundice. Patients were followed for mean duration of 6.3 months. The overall survival was 49 % at 27 months. Fourteen (5.8 %) patients experienced stent occlusion; the mean time to stent occlusion was 6.6 (range 1-20) months. Immediate complications included: post-ERCP pancreatitis (n = 14), stent migration (n = 3), and duodenal perforation (n = 3). Long-term complications included stent migration (n = 9) and hepatic abscess (n = 1). A total of 144/174 patients deemed to have resectable cancer at time of diagnosis underwent curative surgery. Due to disease progression or the discovery of metastasis after neoadjuvant therapy, only 22/67 patients with borderline-resectable cancer underwent curative surgery. 4
16. Emmett DS, Mallat DB. Double-balloon ERCP in patients who have undergone Roux-en-Y surgery: a case series. Gastrointest Endosc. 2007;66(5):1038-1041. Review/Other-Tx 14 patients To report successful use of double-balloon ERCP in patients who have had a Roux-en-Y surgical procedure. Fourteen patients underwent a total of 20 ERCPs with the double-balloon endoscopy system. The ampulla was successfully reached in 85% of total cases (100% of patients who have had Roux-en-Y weight reduction surgery), with adequate cannulation of either the biliary or pancreatic duct in 80% (88% of patients for weight reduction). Therapeutic intervention, including stone removal, pancreatobiliary-duct dilation, sphincterotomy, stent placement, and removal of previously placed stents, was performed successfully in 6 cases. The mean age was 47 years old. The mean (+/- standard deviation) total duration of the procedure was 99 +/- 48 minutes. There were no immediate or short-term complications. 4
17. Kurzynske FC, Romagnuolo J, Brock AS. Success of single-balloon enteroscopy in patients with surgically altered anatomy. Gastrointest Endosc. 2015;82(2):319-324. Review/Other-Tx 48 patients. To evaluate the efficacy, yield, and safety of SBE in patients with surgically altered anatomy. A total of 48 patients met inclusion criteria. Mean age was 56 years (77% female). Eleven patients underwent single-balloon PEG placement, 8 single-balloon ERCP, 22 non-PEG/non-ERCP anterograde SBE, and 7 retrograde SBE. Previous surgeries included Roux-en-Y gastric bypass (n=26), small-intestine resection (n=6), colon resection (n=5), Whipple procedure (n=4), choledochojejunostomy (n=3), hepaticojejunostomy (n=1), Billroth I (n=1), Billroth II (n=1), and Puestow procedure (n=1). Procedural indications were PEG tube placement (n=11), choledocholithiasis (n=2), biliary stricture (n=2), obstructive jaundice (n=1), cholangitis (n=1), ampullary mass (n=1), sphincter of Oddi dysfunction (n=1), anemia and/or bleeding (n=15), abdominal pain (n=9), radiologic evidence of obstruction (n=3), and Peutz-Jeghers syndrome (n=2). The technical success rate was 73% in single-balloon PEG placement, 88% in single-balloon ERCP, 82% in other anterograde SBEs, and 86% in retrograde SBEs. No intraprocedural or postprocedural adverse events were observed. 4
18. Wang AY, Sauer BG, Behm BW, et al. Single-balloon enteroscopy effectively enables diagnostic and therapeutic retrograde cholangiography in patients with surgically altered anatomy. Gastrointest Endosc. 2010;71(3):641-649. Review/Other-Tx 13 patients; 16 procedures To determine the effectiveness of SBE in performing endoscopic retrograde cholangiography (ERC) in patients with surgically altered anatomy. Diagnostic ERC was successful 12 (92.3%) of 13 patients and in 13 (81.3%) of 16 cases. Therapeutic ERC was required in 10 patients in whom diagnostic ERC was first accomplished, and therapeutic ERC was successful in 9 (90%) of 10 patients. Biliary interventions included balloon dilation (n = 4), stone extraction (n = 2), sphincterotomy (n = 4), removal of a surgically placed stent (n = 3), and stenting (n = 2). Two patients developed pancreatitis after therapeutic ERC. Median follow-up was 53 days (range 22-522 days). Overall procedural success in an intent-to-treat analysis by case was 75%. 4
19. Zouhairi ME, Watson JB, Desai SV, et al. Rotational assisted endoscopic retrograde cholangiopancreatography in patients with reconstructive gastrointestinal surgical anatomy. World J Gastrointest Endosc. 2015;7(3):278-282. Review/Other-Tx 42 procedures To evaluate the success rates of performing therapy utilizing a rotational assisted enteroscopy device in endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy patients. Successful visualization of the major ampulla was accomplished in 32 of 42 procedures (76.2%). Cannulation of the bile duct was successful in 26 of 32 procedures reaching the major ampulla (81.3%). Successful therapeutic intervention was completed in 24 of 26 procedures in which the bile duct was cannulated (92.3%). The overall intention to treat success rate was 64.3%. In terms of cannulation success, the intention to treat success rate was 61.5%. Ten out of forty two patients (23.8%) required admission to the hospital after procedure for abdominal pain and nausea, and 3 of those 10 patients (7.1%) had a diagnosis of post-ERCP pancreatitis. The average hospital stay was 3 d. 4
20. Shah RJ, Smolkin M, Yen R, et al. A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video). Gastrointest Endosc. 2013;77(4):593-600. Review/Other-Tx 129 patients; 180 procedures To evaluate and compare ERCP success by using single-balloon (SBE), double-balloon (DBE), or rotational overtube enteroscopy. From January 2008 through October 2009, 129 patients had 180 enteroscopy-ERCPs. Anatomy was Roux-en-Y: gastric bypass (n = 63), hepaticojejunostomy (n = 45), postgastrectomy (n = 6), Whipple procedure (n = 10), and other (n = 5). ERCP success was 81 of 129 (63%). Enteroscopy success: 92 of 129 (71%), of whom 81 of 92 (88%) achieved ERCP success. Reasons for ERCP failure (n = 48): afferent limb entered but pancreaticobiliary anastomosis and/or papilla not reached (n = 23), cannulation failure (n = 11), afferent limb angulation (n = 8), and jejunojejunostomy not identified (n = 6). Select interventions: anastomotic stricturoplasty (cautery +/- dilation, n = 16), stone removal (n = 21), stent (n = 25), and direct cholangioscopy (n = 11). ERCP success rates were similar between Roux-en-Y gastric bypass and other long-limb surgical bypass and among SBE, DBE, and rotational overtube enteroscopy. Complications were 16 of 129, 12.4%. LIMITATIONS: Retrospective study. 4
21. Skinner M, Popa D, Neumann H, Wilcox CM, Monkemuller K. ERCP with the overtube-assisted enteroscopy technique: a systematic review. Endoscopy. 2014;46(7):560-572. Review/Other-Tx 679 patients; 945 procedures To compare the efficacy and safety of overtube-assisted enteroscopy-endoscopic retrograde cholangiopancreatography (OAE-ERCP) in patients with different configurations of upper gastrointestinal anatomy. A total of 23 relevant reports on OAE procedures, including single-balloon, double-balloon, and spiral enteroscopy, were analyzed. Studies included a total of 945 procedures in 679 patients (age 2 - 91 years) who had a variety of postsurgical upper gastrointestinal anatomical configurations. Among patients who underwent Roux-en-Y with gastric bypass, endoscopic success was 80 % and ERCP success was 70 %. In patients who had undergone a Roux-en-Y with either a pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, or hepaticojejunostomy, endoscopic success was 85 % and ERCP success was 76 %. In patients who had undergone a Billroth II procedure, endoscopic success was 96 % and ERCP success was 90 %. In patients with native papilla who underwent successful endoscopy, cannulation was successful in 90 % of patients compared with 92 % in patients with an anastomosis. Overall ERCP success for all attempts was approximately 74 %. Interventions included sphincterotomy, pre-cut papillotomy, anastomotic stricturoplasty, stone removal, stent insertion, stent replacement, and balloon dilation of stenotic anastomosis. There were 32 major complications among the 945 procedures (3.4 %). 4
22. Garcia-Garcia L, Lanciego C. Percutaneous treatment of biliary stones: sphincteroplasty and occlusion balloon for the clearance of bile duct calculi. AJR Am J Roentgenol. 2004;182(3):663-670. Review/Other-Tx 212 patients To describe the percutaneous expulsion of bile duct calculi into the duodenum by dilating the papilla with a balloon catheter. Technical success was initially 90.4%, increasing to 93% at the second attempt.There were 13 failures due to the large size of the calculi in nine patients, excessive tortuosityof the T tube (Kher tube) in one, and breaches of the established protocol in two.Residual lithiasis was resolved in 98.6% of cases, decreasing to 92% in the group of native, ornonresidual, lithiasis. There were 10 major complications (hemobilia) with three cases ofpoor clinical outcome: hepatic necrosis, multiorgan failure, or death. 4
23. Pessa ME, Hawkins IF, Vogel SB. The treatment of acute cholangitis. Percutaneous transhepatic biliary drainage before definitive therapy. Ann Surg. 1987;205(4):389-392. Review/Other-Tx 42 patients To treat patients with fluid and electrolyte resuscitation, broad spectrum antibiotic coverage, and initial percutaneous transhepatic biliary drainage (PTD). Sepsis began to resolve in all patients within 24 hours of PTD, after which definitive cholangiogram was performed. PTD was accompanied by a 7% (3/42) complication rate, none of which contributed to subsequent morbidity and mortality. Two patients in severe septic shock had PTD but died within 8 hours of admission, constituting a 5% mortality rate. Definitive therapy after resolution of sepsis included: surgical (16 patients), internal/external drainage (14 patients), balloon dilatation (10 patients), mono-octanoin infusion (1 patient), and ampullary dilatation (1 patient). The surgical morbidity rate was 18%. There was no mortality. 4
24. Ilgit ET, Gurel K, Onal B. Percutaneous management of bile duct stones. Eur J Radiol. 2002;43(3):237-245. Review/Other-Tx N/A To review the interventional radiological procedures in the percutaneous management of the bile duct stones through T-tube or transhepatic tracts. No results stated in abstract. 4
25. Ozcan N, Kahriman G, Mavili E. Percutaneous transhepatic removal of bile duct stones: results of 261 patients. Cardiovasc Intervent Radiol. 2012;35(4):890-897. Experimental-Tx 261 patients To determine the effectiveness of percutaneous transhepatic removal of bile duct stones when the procedure of endoscopic therapy fails for reasons of anatomical anomalies or is rejected by the patient. Overall success rate was 95.7%. The procedure was successful in 97.5% of patients with CBD stones and in 61.5% of patients with hepatolithiasis. A total of 18 major complications (6.8%), including cholangitis (n = 7), subcapsular biloma (n = 4), subcapsular hematoma (n = 1), subcapsular abscess (n = 1), bile peritonitis (n = 1), duodenal perforation (n = 1), CBD perforation (n = 1), gastroduodenal artery pseudoaneurysm (n = 1), and right hepatic artery transection (n = 1), were observed after the procedure. There was no mortality. 3
26. Calvo MM, Bujanda L, Heras I, et al. The rendezvous technique for the treatment of choledocholithiasis. Gastrointest Endosc. 2001;54(4):511-513. Review/Other-Tx 1753 procedures To study the rendezvous technique that combines endoscopy with percutaneous transhepatic cholangiography to facilitate cannulation of the bile duct when previous attempts have failed. The combined procedure was successful in 13 patients (93%). It was unsuccessful in 1 patient because of a stone lodged distally near the papilla. There was only 1 complication (7%), a retroperitoneal perforation that occurred during papillotomy; no mortality was directly attributable to the technique. 4
27. Okuno M, Iwashita T, Yasuda I, et al. Percutaneous transgallbladder rendezvous for enteroscopic management of choledocholithiasis in patients with surgically altered anatomy. Scand J Gastroenterol. 2013;48(8):974-978. Review/Other-Tx 6 patients To evaluate the feasibility and safety of percutaneous transgallbladder rendezvous (PTGB)-RV in patients with SAA. Six patients with SAA (Roux-en-Y in 4 and Billroth-II in 2) underwent PTGB-RV for removal of bile duct stones. In all patients, a guidewire was successfully inserted into the duodenum followed by insertion of the enteroscope and biliary cannulation. EPBD was then performed, but subsequent stone removal failed in 1 patient. Stone removal was successful in 5 patients without complication, except 1 case of mild pancreatitis. 4
28. Dasari BV, Tan CJ, Gurusamy KS, et al. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev. 2013(9):CD003327. Review/Other-Tx 1758 patients; 16 randomised clinical trials To systematically review the benefits and harms of different approaches to the management of common bile duct stones. Sixteen randomised clinical trials with a total of 1758 randomised participants fulfilled the inclusion criteria of this review. Eight trials with 737 participants compared open surgical clearance with endoscopic retrograde cholangiopancreatography (ERCP); five trials with 621 participants compared laparoscopic clearance with pre-operative ERCP; and two trials with 166 participants compared laparoscopic clearance with postoperative ERCP. One trial with 234 participants compared laproscopic common bile duct exploration (LCBDE) with intra-operative ERCP. There were no trials of open or LCBDE versus ERCP in people without an intact gallbladder. All trials had a high risk of bias.There was no significant difference in the mortality between open surgery versus ERCP clearance (eight trials; 733 participants; 5/371 (1%) versus 10/358 (3%) OR 0.51;95% CI 0.18 to 1.44). Neither was there a significant difference in the morbidity between open surgery versus ERCP clearance (eight trials; 733 participants; 76/371 (20%) versus 67/358 (19%) OR 1.12; 95% CI 0.77 to 1.62). Participants in the open surgery group had significantly fewer retained stones compared with the ERCP group (seven trials; 609 participants; 20/313 (6%) versus 47/296 (16%) OR 0.36; 95% CI 0.21 to 0.62), P = 0.0002.There was no significant difference in the mortality between LC + LCBDE versus pre-operative ERCP +LC (five trials; 580 participants; 2/285 (0.7%) versus 3/295 (1%) OR 0.72; 95% CI 0.12 to 4.33). Neither was there was a significant difference in the morbidity between the two groups (five trials; 580 participants; 44/285 (15%) versus 37/295 (13%) OR 1.28; 95% CI 0.80 to 2.05). There was no significant difference between the two groups in the number of participants with retained stones (five trials; 580 participants; 24/285 (8%) versus 31/295 (11%) OR 0.79; 95% CI 0.45 to 1.39).There was only one trial assessing LC + LCBDE versus LC+intra-operative ERCP including 234 participants. There was no reported mortality in either of the groups. There was no significant difference in the morbidity, retained stones, procedure failure rates between the two intervention groups.Two trials assessed LC + LCBDE versus LC+post-operative ERCP. There was no reported mortality in either of the groups. There was no significant difference in the morbidity between laparoscopic surgery and postoperative ERCP groups (two trials; 166 participants; 13/81 (16%) versus 12/85 (14%) OR 1.16; 95% CI 0.50 to 2.72). There was a significant difference in the retained stones between laparoscopic surgery and postoperative ERCP groups (two trials; 166 participants; 7/81 (9%) versus 21/85 (25%) OR 0.28; 95% CI 0.11 to 0.72; P = 0.008.In total, seven trials including 746 participants compared single staged LC + LCBDE versus two-staged pre-operative ERCP + LC or LC + post-operative ERCP. There was no significant difference in the mortality between single and two-stage management (seven trials; 746 participants; 2/366 versus 3/380 OR 0.72; 95% CI 0.12 to 4.33). There was no a significant difference in the morbidity (seven trials; 746 participants; 57/366 (16%) versus 49/380 (13%) OR 1.25; 95% CI 0.83 to 1.89). There were significantly fewer retained stones in the single-stage group (31/366 participants; 8%) compared with the two-stage group (52/380 participants; 14%), but the difference was not statistically significant OR 0.59; 95% CI 0.37 to 0.94).There was no significant difference in the conversion rates of LCBDE to open surgery when compared with pre-operative, intra-operative, and postoperative ERCP groups. Meta-analysis of the outcomes duration of hospital stay, quality of life, and cost of the procedures could not be performed due to lack of data. 4
29. Alkhatib AA, Hilden K, Adler DG. Comorbidities, sphincterotomy, and balloon dilation predict post-ERCP adverse events in PSC patients: operator experience is protective. Dig Dis Sci. 2011;56(12):3685-3688. Observational-Tx 75 patients To describe the frequency and risk factors for post-ERCP adverse events in patients with PSC via multivariate analysis. A total of 185 procedures were performed on 75 PSC patients (58 M,17 F). Seven endoscopists performed ERCPs. Comorbidies included ulcerative colitis (44%, n = 33), Crohn's disease (12%, n = 9 patients), Cirrhosis (8%, n = 6 patients) and autoimmune hepatitis (2.7%, n = 2). Cannulation was achieved using dye-free guidewire cannulation techniques in 139/185 procedures (76%) and with contrast-based techniques in 46/185 procedures (24%). Thirty-day post-ERCP adverse events included post-ERCP pancreatitis (5%, n = 9, cholangitis (1%, n = 2), acute cholecystitis (0.5%, n = 1), stent occlusion (0.5%, n = 1), stent migration (0.5%, n = 1), and bile leak (0.5%, n = 1). In the multivariate analysis, associations with specific endoscopists who performed the procedure (P = 0.01), biliary dilation (P = 0.02), sphincterotomy (P = 0.03), presence of cirrhosis (P = 0.05), Crohn's disease (P < 0.001), and autoimmune hepatitis (P < 0.001) significantly predicted a complication following ERCP. Gender, stenting during procedure, presence of a dominant stricture, and cholangitis were not predictive for post-ERCP adverse events. 3
30. Smith T, Befeler AS. High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. Curr Gastroenterol Rep. 2007;9(1):54-59. Review/Other-Tx N/A No objective stated in abstract. No results stated in abstract. 4
31. Shenoy SM, Shenoy S, Gopal S, Tantry BV, Baliga S, Jain A. Clinicomicrobiological analysis of patients with cholangitis. Indian J Med Microbiol. 2014;32(2):157-160. Review/Other-Tx 348 patients To determine the factors responsible for cholangitis and the microbiological profile of the bile in patients with cholangitis. In the study involving 348 patients, 36.4% had associated malignancy. A total of 54% of the bile samples were positive for aerobic culture. Nearly 66-73% of the Escherichia coli and Klebsiella isolates were Extended spectrum beta lactamases (ESBL) producers. Two isolates of Candida spps were also obtained. Polymicrobial infection was seen in 31.5% of the culture positive cases. 4
32. Tabibian JH, Gossard A, El-Youssef M, et al. Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis. Am J Ther. 2017;24(1):e56-e63. Observational-Tx 16 patients To investigate the efficacy and safety of 550 mg of oral rifaximin twice daily. After 12 weeks of treatment, there were no significant changes in ALK (median increase of 0.9% to 345 IU/mL; P = 0.47) or any of the secondary biochemical end points (all P > 0.05). Similarly, there were no significant changes in fatigue impact scale, chronic liver disease questionnaire, or SF-36 scores (all P > 0.05). Three patients withdrew from the study due to AEs; 4 others reported mild AEs but completed the study. 2
33. Rahimpour S, Nasiri-Toosi M, Khalili H, Ebrahimi-Daryani N, Nouri-Taromlou MK, Azizi Z. A Triple Blinded, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis: a Pilot Study. J Gastrointestin Liver Dis. 2016;25(4):457-464. Experimental-Tx 29 patients To evaluate the efficacy of oral vancomycin in patients with sclerosing cholangitis (PSC). 29 patients with a mean age of 36.27+/-10.60 years were included in the study. Primary endpoints were accomplished in the vancomycin group showing a significant decline in the mean level of PSC Mayo risk score (decrease rate 3rd month - baseline = -322.03%, p=0.026) during follow up time. Moreover, the analysis of the level of alkaline phosphatase (ALP) in the vancomycin group showed a significant decrease in the third month of treatment as compared to its level in the first month (mean difference 3rd month -1st month = -142.92, Decrease rate= -18.24%, p=0.02). Among secondary endpoints, erythrocyte sedimentation rate (p=0.005), gamma-glutamyl transpeptidase (p=0.02) and patients' symptoms including fatigue, pruritus, diarrhea and anorexia showed a significant decrease in the vancomycin group. 1
34. Farkkila M, Karvonen AL, Nurmi H, et al. Metronidazole and ursodeoxycholic acid for primary sclerosing cholangitis: a randomized placebo-controlled trial. Hepatology. 2004;40(6):1379-1386. Experimental-Tx 80 patients To evaluate the effect of ursodeoxycholic acid (UDCA) and metronidazole (MTZ) compared with UDCA/placebo on the progression of PSC. Assessment of liver function test, histological stage and grade, and cholangiography (via ERCP) at baseline showed no differences between the groups. After 36 months, serum aminotransferases gamma-glutamyltransferase, and alkaline phosphatase (ALP) decreased markedly in both groups, serum ALP more significantly in the UDCA/MTZ group (-337 +/- 54 U/L, P < .05) compared with the UDCA/placebo group. The New Mayo Risk Score decreased markedly only in the UDCA/MTZ group (-0.50 +/- 0.13, P < .01). The number of patients with improvement of stage (P < .05) and grade (P < .05) was higher in the combination group. ERCP findings showed no progression or improvement in 77% and 68% of patients on UDCA/MTZ and UDCA/placebo, respectively. 1
35. Aljiffry M, Renfrew PD, Walsh MJ, Laryea M, Molinari M. Analytical review of diagnosis and treatment strategies for dominant bile duct strictures in patients with primary sclerosing cholangitis. HPB (Oxford). 2011;13(2):79-90. Review/Other-Dx N/A To appraise and synthesize the evidence published in the English-language medical literature on the diagnosis and treatment of indeterminate dominant strictures (DS) in patients with primary sclerosing cholangitis (PSC). Strategies for the optimal management of DS in PSC patients are supported only by level II and III evidence. Intraductal endoscopic ultrasound appears to be the most sensitive (64%) and specific (95%) diagnostic test for the evaluation of DS in PSC. Endoscopic and percutaneous dilatations achieve 1- and 3-year palliation in 80% and 60% of patients, respectively. Although dilatation and stenting are the most common palliative interventions in DS, no randomized trials on the optimal duration of treatment have been conducted. 4
36. Hammel P, Couvelard A, O'Toole D, et al. Regression of liver fibrosis after biliary drainage in patients with chronic pancreatitis and stenosis of the common bile duct. N Engl J Med. 2001;344(6):418-423. Observational-Tx 11 patients To study liver-biopsy specimens from 11 patients with chronic stenosis of the common bile duct due to chronic pancreatitis. The two patients who had restenosis of the biliary anastomosis were excluded from the analysis of fibrosis. In the group of nine patients without restenosis, the second specimen showed significant improvement in fibrosis (P=0.01). The fibrosis improved by two grades in two patients and by one grade in four patients; in three patients, the grade did not change. The pathologists agreed on the grading of specimens from 10 of the 11 patients. 3
37. May GR, Bender CE, LaRusso NF, Wiesner RH. Nonoperative dilatation of dominant strictures in primary sclerosing cholangitis. AJR Am J Roentgenol. 1985;145(5):1061-1064. Observational-Dx 14 patients To assess the efficacy and safety of percutaneous balloon dilatation of dominant strictures in symptomatic patients with primary sclerosing cholangitis. Stricture dilatation produced a significant decrease in the frequency of cholangitis and a significant decrease in serum bilirubin in those with recent onset of jaundice. The only complication was bacteremia or cholangitis in five patients. Three of nine patients with successful dilatations developed recurrent strictures at 6-18 months. 3
38. Chapman MH, Webster GJ, Bannoo S, Johnson GJ, Wittmann J, Pereira SP. Cholangiocarcinoma and dominant strictures in patients with primary sclerosing cholangitis: a 25-year single-centre experience. Eur J Gastroenterol Hepatol. 2012;24(9):1051-1058. Review/Other-Tx 128 patients To compare the outcome of a large series of patients with PSC with and without dominant biliary strictures managed at a single tertiary referral centre over a 25-year period, with a particular emphasis on the safety and efficacy of endoscopic therapy. Eighty patients (62.5%) with dominant biliary strictures had a median of 3 (range 0-34) interventions, compared with 0 (0-7) in the 48 patients without dominant strictures (P<0.001). Endoscopic interventions included the following: (i) stenting alone (46%), (ii) dilatation alone (20%), (iii) dilatation and stenting (17%) and (iv) none or failed intervention (17%, of whom most required percutaneous transhepatic drainage). The major complication rate for endoscopic retrograde cholangiopancreatography was low (1%). The mean survival of those with dominant strictures (13.7 years) was worse than that for those without dominant strictures (23 years), with much of the survival difference related to a 26% risk of CC developing only in those with dominant strictures. Half of those with CC presented within 4 months of the diagnosis of PSC, highlighting the importance of a thorough evaluation of new dominant strictures. 4
39. Ponsioen CY, Lam K, van Milligen de Wit AW, Huibregtse K, Tytgat GN. Four years experience with short term stenting in primary sclerosing cholangitis. Am J Gastroenterol. 1999;94(9):2403-2407. Experimental-Tx 32 patients To report a 4 yr experience with short term endoscopic stent therapy for relief of dominant strictures. Cholestatic complaints improved after 2 months in 83% of patients. Mean scores for pruritus, fatigue, and right upper quadrant pain decreased from 0.94, 1.0, and 0.87 to 0.26, 0.39, and 0.26, respectively. All improvements were significant. Of 14 patients presenting with jaundice, 12 regained normal serum bilirubin levels 2 months after short term endoscopic stenting. The mean levels of conjugated bilirubin, alkaline phosphatase, and gamma-glutamyl transpeptidase dropped significantly from 36 micromol/L, 309 U/L, and 426 U/L to 7 micromol/L, 205 U/L, and 258 U/L, respectively. The reintervention-free proportions after 1 and 3 yr were 80% and 60%. Seven transient procedure-related complications occurred in 45 therapeutic endoscopic retrograde cholangiopancreatographies. 2
40. Cote GA, Kumar N, Ansstas M, et al. Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents. Gastrointest Endosc. 2010;72(4):748-754. Observational-Dx 544 patients To compare rates of post-ECRP pancreatitis (PEP) in patients who undergo biliary drainage with SEMSs or polyethylene stents (PSs). We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 [95% CI, 1.9-17.1]). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 [CI, 0.3-2.4]). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. 3
41. Ahrendt SA, Pitt HA, Kalloo AN, et al. Primary sclerosing cholangitis: resect, dilate, or transplant? Ann Surg. 1998;227(3):412-423. Observational-Tx 146 patients To examine the results of extrahepatic biliary resection, nonoperative endoscopic biliary dilation with or without percutaneous stenting, and liver transplantation in the management of patients with primary sclerosing cholangitis (PSC). Procedure-related morbidity and mortality rates were similar between surgically resected and nonoperatively managed patients. In noncirrhotic patients, the serum bilirubin level was significantly (p < 0.05) reduced from preoperative levels (8.3+/-1.5 mg/dL) 1 (1.7+/-0.4 mg/dL) and 3 (2.7+/-0.9 mg/ dL) years after resection, but not after endoscopic or percutaneous management. For noncirrhotic PSC patients, overall 5-year survival (85% vs. 59%) and survival until death or transplantation (82% vs. 46%) were significantly longer (p < 0.05) after resection than after nonoperative dilation with or without stenting. For cirrhotic patients, survival after liver transplantation was longer than after resection or nonoperative dilation with or without stenting. Five patients developed cholangiocarcinoma, including three (6%) of the nonoperatively managed patients but none of the resected patients. 2
42. Pawlik TM, Olbrecht VA, Pitt HA, et al. Primary sclerosing cholangitis: role of extrahepatic biliary resection. J Am Coll Surg. 2008;206(5):822-830; discussion 830-822. Observational-Tx 126 patients To investigate the role of EHBR and determine perioperative morbidity and longterm survival in the largest cohort of patients with the longest followup of any series published to date. Of 77 patients undergoing EHBR, mean preoperative bilirubin level was 5.6 mg/dL. Nine (11.7%) patients had cirrhosis.Most patients had preoperative biliary drainage (ERCP, 61.0%; PTC, 67.5%). At operation, 73 (94.8%) patients underwent EHBR, including hepatic duct bifurcation. Most patients also had insertion of bilateral transhepatic silicone elastomer biliary stents; 4 (5.2%) underwent EHBR with stent insertion plus hepatectomy. For EHBR patients, perioperative complication rate was 38.7% and 30-day mortality was 3.9%. Bilirubin levels significantly decreased postoperatively (mean drop 3.8 mg/dL; p0.01). At 3 years, 57.1% of patients had no PSC-related readmissions, and 16.2% had more than 3. At a median followup of 10.5 years, 5- and 10-year survival was 76.4% and 52.7%, respectively. Cholangiocarcinoma did not develop in any patients, and only seven required OLT. Factors associated with worse survival included postoperative bilirubin2 mg/dL and history of cirrhosis (both p0.001). In patients undergoing EHBR, noncirrhotic patients had significantly better longterm outcomes versus cirrhotic patients (10-year survival, 60.2% versus 12.0%; p0.001). In contrast, 10-year survival of OLT patients with cirrhosis was 57.0%. 2
43. Tsai S, Pawlik TM. Primary sclerosing cholangitis: the role of extrahepatic biliary resection. Adv Surg. 2009;43:175-188. Review/Other-Tx N/A No objective stated in abstract. No results stated in abstract. 4
44. Baccarani U, Risaliti A, Zoratti L, et al. Role of endoscopic retrograde cholangiopancreatography in the diagnosis and treatment of biliary tract complications after orthotopic liver transplantation. Dig Liver Dis. 2002;34(8):582-586. Review/Other-Dx 132 patients To analyse, in a single centre, experience in endoscopic diagnosis and management of biliary complications after liver transplantation. Endoscopic retrograde cholangiopancreatography was performed on 30 patients (23%). Overall incidence of biliary complications as confirmed by endoscopic retrograde cholangiopancreatography was 17% (25 cases). Endoscopic retrograde cholangiopancreatography was negative in 5 cases (16%). Biliary complications were successfully treated by endoscopy in 84% of cases (21 out of 25 patients); 4 cases (16%) required a surgical approach (2 choledochojejunostomy, 2 retransplantation) due to failure to correct the problem endoscopically. Stenoses and biliary sludge associated with retained internal stent were almost always successfully managed by endoscopic retrograde cholangiopancreatography, while anastomotic leakage more frequently required a surgical approach. 4
45. Fleck A, Zanotelli ML, Meine M, et al. Biliary tract complications after orthotopic liver transplantation in adult patients. Transplant Proc. 2002;34(2):519-520. Review/Other-Tx 150 patients To analyze the incidence of biliary complications (BC) after Orthotopic Liver Transplantation (OLT), the type of complication and timing, and the treatment performed in three different groups. A total of 23 patients (15.3%) had some type of BC (Table 1). In this group only one recipient (4%) died due to the BC. The most common early complication was biliary leak. Biliary strictures and stones appeared later. Three patients who had BC due to ischemia were not included; they underwent retransplantation. Seven of the nine patients with biliary leak were treated by surgery and two by (ERCP). All cases of biliary stones were resolved by ERCP with papillotomy. Of the seven patients who had strictures, three were treated by surgery, two by ERCP, and one by percutaneous biliary dilatation. One patient with stricture improved with conservative treatment. 4
46. Memeo R, Piardi T, Sangiuolo F, Sommacale D, Pessaux P. Management of biliary complications after liver transplantation. World J Hepatol. 2015;7(29):2890-2895. Review/Other-Tx N/A To review and focus on the treatment of BC after LT. No results stated in abstract. 4
47. Gastaca M. Biliary complications after orthotopic liver transplantation: a review of incidence and risk factors. Transplant Proc. 2012;44(6):1545-1549. Review/Other-Tx N/A To review the incidence of and risk factors for biliary complications (BCs) after deceased donor liver transplantation (DDLT). No results stated in abstract. 4
48. Thuluvath PJ, Pfau PR, Kimmey MB, Ginsberg GG. Biliary complications after liver transplantation: the role of endoscopy. Endoscopy. 2005;37(9):857-863. Review/Other-Dx N/A To discuss the role of endoscopy in the diagnosis, treatment options, and the outcome for patients with biliary complications following liver transplantation. No results stated in abstract. 4
49. Gwon DI, Sung KB, Ko GY, Yoon HK, Lee SG. Dual catheter placement technique for treatment of biliary anastomotic strictures after liver transplantation. Liver Transpl. 2011;17(2):159-166. Experimental-Tx 70 patients To evaluate the results of percutaneous transhepatic management of anastomotic biliary strictures using the dual catheter placement technique (2 drainage catheters inserted via single percutaneous tract). Technical success was achieved in all 79 (100%) patients after percutaneous transhepatic treatment. The mean period of dual catheter placement was 6.5 6 1.1 months (range, 5.5-14.2 months). Clinical success was achieved in 78 (98.7%) of 79 patients and drainage catheters were removed 23.8 6 8.8 months (range, 11.4-43.3 months) after the initial percutaneous transhepatic biliary drainage. Procedure-related complications occurred in 14 (17.8%) patients. During the mean followup period of 34.5 6 3 months (range, 24.4-38.5 months) in the 78 patients, the primary patency rates were 96%, 92%, and 91% at 1, 2, and 3 years, respectively. Seven (9%) of the 78 patients experienced recurrent symptoms at a mean of 15.4 6 8.9 months (range, 6.1-26.2 months) after catheter removal. 2
50. Kulaksiz H, Weiss KH, Gotthardt D, et al. Is stenting necessary after balloon dilation of post-transplantation biliary strictures? Results of a prospective comparative study. Endoscopy. 2008;40(9):746-751. Experimental-Tx 32 patients To evaluate balloon dilation vs. balloon dilation plus stenting with regard to technical and clinical efficacy as well as complications. The initial technical success and primary clinical success rates in the dilation group were both 100%; in the stent group, the corresponding rates were 100% and 93% (n. s.). The sustained clinical success was 71% vs. 73%, respectively (n. s.). The time interval to reach sustained clinical success was 6.1 and 5.1 months, respectively (n. s.). No significant differences were found in assisted clinical success or in treatment failure. Complications were observed in 4.3% in the dilation group and 13.6% in the stent group (P < 0.05). Independent of the treatment group, a sustained clinical success in anastomotic strictures was achieved in 100%, whereas the success rate of strictures of the donor hepatic duct was 50% and of strictures involving the hilum, only 14% (P < 0.05). 2
51. Aparicio D, Otoch JP, Montero EFS, Khan MA, Artifon ELA. Endoscopic approach for management of biliary strictures in liver transplant recipients: A systematic review and meta-analysis. United European Gastroenterol J. 2017;5(6):827-845. Meta-analysis 7 studies To compare different endoscopic techniques to treat post-liver transplantation biliary strictures. The endoscopic treatment of anastomotic stricture (AS) was equally effective when compared the use of fully covered self-expandable metal stents (FCSEMS) vs. plastic stents, but the use of FCSEMS was associated with a lower complication risk. Good
52. Kaffes A, Griffin S, Vaughan R, et al. A randomized trial of a fully covered self-expandable metallic stent versus plastic stents in anastomotic biliary strictures after liver transplantation. Therap Adv Gastroenterol. 2014;7(2):64-71. Experimental-Tx 20 patients To determine whether fully covered self-expanding metal stents (FCSEMSs) decrease overall numbers of endoscopic retrograde cholangiopancreatographies (ERCPs) needed to achieve stricture resolution and to establish the safety, efficacy and cost-effectiveness in this setting. The median number of ERCPs performed per patient in the FCSEMS was 2 versus 4.5 (p = 0.0001) in the plastic stenting arm. Stricture resolution was achieved in all 10 patients with FCSEMSs compared with 8/10 in the plastic arm [p = not significant (NS)]. Complications occurred in 1/10 patients in the FCSEMS arm versus 5/10 in the plastic arm (p = 0.051). Days in hospital for complications was 6 in the FCSEMS versus 56 in the plastic arm (p = 0.11). Cost analysis shows that the FCSEMS arm was more cost effective. No cases of FCSEMS migration were seen. 1
53. Hisatsune H, Yazumi S, Egawa H, et al. Endoscopic management of biliary strictures after duct-to-duct biliary reconstruction in right-lobe living-donor liver transplantation. Transplantation. 2003;76(5):810-815. Observational-Tx 73 patients To characterize the features of the biliary strictures that occur after duct-to-duct biliary reconstruction during right-lobe living-donor liver transplantation (LDLT) and to evaluate the feasibility of correcting such stricture endoscopically by inserting an "inside stent," that is, a short internal stent, above the sphincter of Oddi. ERC disclosed biliary stricture in 19 (86.4%) of the 22 patients who underwent the procedure. One patient had an unbranched stricture, 16 had a fork-shaped stricture, 1 had a trident-shaped stricture, and 1 had a stricture with more than three branches. Fourteen (73.7%) of the patients with strictures were treated endoscopically by inserting inside stents ranging from 7 F to 12 F in size, three underwent a Roux-en-Y hepaticojejunostomy to repair their stricture, and two were closely observed as outpatients. Of the 14 patients who were treated with the inside-stent, only 1 had acute cholangitis immediately after the procedure and underwent a Roux-en-Y hepaticojejunostomy. The other 13 patients who were treated with the inside stent have not required surgical repair for as long as an average of 586 days. 2
54. Wadhawan M, Kumar A. Management issues in post living donor liver transplant biliary strictures. World J Hepatol. 2016;8(10):461-470. Review/Other-Tx N/A To study biliary complications after living donor liver transplant (LDLT) while considering advancements in surgical understanding and techniques that are leading to decreasing incidence. Long-term outcome of patients with biliary stricture is similar to those without stricture. With the introduction of new generation cholangioscopes, ERCP success rate may increase, obviating the need for PTBD and surgery in these patients. 4
55. Lee SH, Ryu JK, Woo SM, et al. Optimal interventional treatment and long-term outcomes for biliary stricture after liver transplantation. Clin Transplant. 2008;22(4):484-493. Observational-Tx 79 patients To undertake an evaluation of the clinical outcomes of endoscopic cholangioplasty (ECP) and percutaneous cholangioplasty (PCP) for biliary strictures after liver transplantation. Successful intervention rates (60.0% in ECP vs. 59.3% in PCP, p = 1.00) and patencies after successful intervention (44.8 +/- 7.4 months in ECP vs. 41.9 +/- 3.4 months in PCP, p = 0.47) were no different for the two techniques. However, the number of intervention sessions for PCP (7.2 +/- 0.6) was higher than for ECP (2.9 +/- 0.6) (p < 0.01). Multivariate analysis showed that only an anastomotic stricture was found to be related with a longer patency with an estimated odds ratio of 5.74 (p = 0.04) and had a tendency to be associated with successful intervention with an estimated odds ratio of 3.12 (p = 0.07) irrespective of techniques. 2
56. Wadhawan M, Kumar A, Gupta S, et al. Post-transplant biliary complications: an analysis from a predominantly living donor liver transplant center. J Gastroenterol Hepatol. 2013;28(6):1056-1060. Review/Other-Tx 65 patients To report our experience from an donor liver transplantation (LDLT) program. Sixty-five patients had biliary complications (19%). Of these, 30 were biliary leaks, and 35 patients had biliary stricture. Four were cut surface leaks, which settled without any intervention. One patient had leak from primary hepaticojejunostomy, which settled on conservative management. Twenty-five patients had anastomotic leaks, of which 17 underwent endoscopic retrograde cholangiopancreatography and stenting; another eight underwent re-exploration and hepaticojejunostomy. Forty-five patients had biliary strictures. Of these, 10 patients had bile leak initially, followed by biliary stricture. Patients with a double duct anastomosis had a significantly higher risk of developing biliary complications compared with those with a single duct anastomosis. There was no statistically significant difference in survival between those with or without biliary complications. 4
57. Rieber A, Brambs HJ, Lauchart W. The radiological management of biliary complications following liver transplantation. Cardiovasc Intervent Radiol. 1996;19(4):242-247. Experimental-Tx 22 patients To demonstrate the radiological management of biliary complications following liver transplantation. In 6 patients percutaneous transhepatic cholangiography (PTC) revealed anastomotic, and in 6 patients nonanastomotic biliary strictures. Four patients had intrahepatic stones. Biliary strictures were treated by implantation of Palmaz stents in 5 of 6 patients with anastomotic strictures, and in 3 of 6 patients with nonanastomotic strictures. The intrahepatic stones were fragmented with dye laser lithotripsy under cholangioscopic control in 3 of 4 patients. One spontaneous stent migration after 24 months and one stent occlusion were observed; the remaining stents are still patent. Patients with anastomotic strictures had a more favorable outcome: 5 of 6 of these patients are still alive and symptom-free after an average of 27.4 months, but only 3 of 6 patients with nonanastomotic strictures are alive after an average of 9.8 months. 1
58. Righi D, Cesarani F, Muraro E, Gazzera C, Salizzoni M, Gandini G. Role of interventional radiology in the treatment of biliary strictures following orthotopic liver transplantation. Cardiovasc Intervent Radiol. 2002;25(1):30-35. Experimental-Tx 33 patients To evaluate the efficacy and safety of percutaneous treatment of biliary strictures complicating orthotopic liver transplantation (OLT). After one to three treatments 24 of 33 (73%) patients were stricture-free on ultrasound and MR cholangiography follow-up. A delayed stricture recurrence required a fourth percutaneous bilioplasty in two of 33 (6%) patients. A surgical bilioenteric anastomosis was performed in six of 33 (18%) patients. Retransplantation was performed due to ischemic damage in one of 33 (3%) patients. 2
59. Stratta RJ, Wood RP, Langnas AN, et al. Diagnosis and treatment of biliary tract complications after orthotopic liver transplantation. Surgery. 1989;106(4):675-683; discussion 683-674. Observational-Dx 132 adults; 94 children To study biliary tract complications as continuing sources of morbidity after liver transplantation. Fifty (19.1%) biliary complications occurred, and 35 (13.4%) necessitated operative repair. The incidence was similar in adults and children and after each method of reconstruction. Risk factors were vascular thrombosis and reduced-sized transplants. Diagnosis was based on the algorithmic use of multiple modalities with early biliary visualization. Roux limb complications usually occurred in the first month after transplant and necessitated operative intervention, whereas duct-to-duct problems appeared later and were more accessible to percutaneous or endoscopic manipulations. Eight (6.8%) patients required conversion to a Roux limb, whereas 8/15 (53.3%) cases of biliary stricture were successfully managed nonoperatively. Three (1.3%) patients and four (1.5%) grafts were lost as a result of biliary complications. One-year actuarial patient survival is 76.4% with a mean follow-up of 13.2 months. 2
60. Flum DR, Cheadle A, Prela C, Dellinger EP, Chan L. Bile duct injury during cholecystectomy and survival in medicare beneficiaries. JAMA. 2003;290(16):2168-2173. Observational-Tx 1,570,361 patients To demonstrate the relation between CBD injury and survival and to identify the factors associated with improved survival among Medicare beneficiaries. Of the 1 570 361 patients identified as having had a cholecystectomy (62.9% women), 7911 patients (0.5%) had CBD injuries. The entire population had a mean (SD) age of 71.4 (10.2) years. Thirty-three percent of all patients died within the 9.2-year follow-up period (median survival, 5.6 years; interquartile range, 3.2-7.4 years), with 55.2% of patients without and 19.5% with a CBD injury remained alive. The adjusted hazard ratio (HR) for death during the follow-up period was significantly higher (2.79; 95% confidence interval [CI]; 2.71-2.88) for patients with a CBD injury than those without CBD injury. The hazard significantly increased with advancing age and comorbidities and decreased with the experience of the repairing surgeon. The adjusted hazard of death during the follow-up period was 11% greater (HR, 1.11; 95% CI, 1.02-1.20) if the repairing surgeon was the same as the injuring surgeon. 2
61. Thompson CM, Saad NE, Quazi RR, Darcy MD, Picus DD, Menias CO. Management of iatrogenic bile duct injuries: role of the interventional radiologist. [Review]. Radiographics. 33(1):117-34, 2013 Jan-Feb. Review/Other-Dx N/A To describe the manifestations, diagnosis, classification, and management of iatrogenic bile duct injuries, with emphasis on the role of the interventional radiologist. No results stated in abstract. 4
62. Lau WY, Lai EC, Lau SH. Management of bile duct injury after laparoscopic cholecystectomy: a review. ANZ J Surg. 2010;80(1-2):75-81. Review/Other-Tx N/A To review the management of bile duct injury after cholecystectomy. Early recognition of bile duct injury is of paramount importance. Only 25%-32.4% of injuries are recognized during operation. The majority of patients present initially with non-specific symptoms. Management depends on the timing of recognition, the type, extent and level of the injury. Immediate recognition and repair are associated with improved outcome, and the minimum standard of care after recognition of bile duct injury is immediate referral to a surgeon experienced in bile duct injury repair. There is a growing body of literature supporting the importance of early referral to a tertiary care hospital which can provide a multidisciplinary approach to treat bile duct injury. Inadequate management may lead to severe complications. 4
63. Bismuth H. Postoperative strictures of the bile ducts. In: Blumgart LH, ed. The Biliary Tract V. New York, NY: Churchill-Livingstone; 1982:209-218. Review/Other-Dx Book Chapter Book Chapter Book Chapter 4
64. Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995;180(1):101-125. Review/Other-Dx N/A To analyse the problem of biliary injury during laparoscopic cholecystectomy. No abstract available. 4
65. Bektas H, Schrem H, Winny M, Klempnauer J. Surgical treatment and outcome of iatrogenic bile duct lesions after cholecystectomy and the impact of different clinical classification systems. Br J Surg. 2007;94(9):1119-1127. Review/Other-Dx 74 patients To validate several different clinical classification systems comparatively. Additional vascular lesions were found in 19 per cent. The hospital mortality rate was 3 per cent and the overall hospital complication rate after repair was 26 per cent. Sixteen of 74 patients required early surgical reintervention. The Hannover classification demonstrated a highly significant association between the discrimination of classifiable injury patterns and the different surgical treatments chosen (P < 0.005). The Strasberg and Neuhaus classifications do not consider vascular involvement, whereas the Stewart-Way, Siewert and Neuhaus systems do not discriminate between lesions at or above the bifurcation of the hepatic duct. 4
66. Weber A, Feussner H, Winkelmann F, Siewert JR, Schmid RM, Prinz C. Long-term outcome of endoscopic therapy in patients with bile duct injury after cholecystectomy. J Gastroenterol Hepatol. 2009;24(5):762-769. Observational-Tx 44 patients To evaluate long-term follow up of endoscopic treatment in biliary lesions after cholecystectomy. In 34 of 35 patients (97%) with peripheral bile duct leakages, endoscopic therapy was successful. Transpapillary endoprothesis and/or nasobiliary drainage were removed after 31 (5-399) days. After stent removal, the median follow-up period was 81 (11-137) months. In patients with central bile duct leakages, the success rate after median 90 (4-145) days of endoscopic therapy was 66.7% (6/9 patients). The median follow up after stent removal in six successfully treated patients was 70 (48-92) months. Eleven of 12 patients (91.6%) with bile duct strictures had successfully completed stent therapy. The follow-up period of this patient group was 99 (53-140) months. 2
67. Barbier L, Souche R, Slim K, Ah-Soune P. Long-term consequences of bile duct injury after cholecystectomy. J Visc Surg. 2014;151(4):269-279. Review/Other-Tx N/A To address late complications of BDI, theirmanagement and the quality of life of patients having sus-tained a post-cholecystectomy BDI. No results stated in abstract. 4
68. Misra S, Melton GB, Geschwind JF, Venbrux AC, Cameron JL, Lillemoe KD. Percutaneous management of bile duct strictures and injuries associated with laparoscopic cholecystectomy: a decade of experience. J Am Coll Surg. 2004;198(2):218-226. Observational-Tx 51 patients To evaluate long-term outcomes for patients undergoing definitive percutaneous management of major bile duct strictures associated with laparoscopic cholecystectomy (LC). All patients completed treatment, and 50 (98%) were stent free at mean followup of 76 months. The success rate of percutaneous management was 58.8%, without need for subsequent intervention. Presenting symptoms, level of injury, and number of stents or dilatations did not predict outcomes. Percutaneous treatment was more likely to fail in patients stented for less than 4 months (p < 0.001). Operative repair at Hopkins before percutaneous management was predictive of a successful outcome (p < 0.05). Including subsequent operations or percutaneous management, successful outcomes were achieved in 98% of patients. 2
69. Saad WE, Darcy MD. Percutaneous management of biliary leaks: biliary embosclerosis and ablation. Tech Vasc Interv Radiol. 2008;11(2):111-119. Review/Other-Dx N/A To discuss the techniques used for biliary leak site embosclerosis/ablation (including biliary-cutaneous tract ablation) and biliary segmental ablation. No results stated in abstract. 4
70. Draganov P, Hoffman B, Marsh W, Cotton P, Cunningham J. Long-term outcome in patients with benign biliary strictures treated endoscopically with multiple stents. Gastrointest Endosc. 2002;55(6):680-686. Observational-Tx 29 cases To evaluate the long-term outcome (bile duct patency, complications) of this therapy and to identify predictors of a good outcome. Stricture etiology was as follows: postoperative 19 (66%), chronic pancreatitis 9 (31%), and idiopathic 1 (3%). Therapy succeeded in 18 patients (62%) (mean follow-up 48.0 [11.56] months after stent removal). Therapy failed in 11 patients (38%) (mean interval to failure 11.59 [9.79] months after stent removal). The 2 groups of patients in which therapy failed had either a hilar stricture (n = 4, 25% success) or distal common bile duct stricture caused by chronic pancreatitis (n = 9, 44% success). In the remaining cases, therapy succeeded in 13 of 16 (81% success). The observed differences in success rate among subgroups were not statistically significant. There were no ERCP-related deaths. One episode of mild pancreatitis and 2 episodes of cholangitis developed during 126 ERCPs over a period of stent insertion of 36 patient years. 2
71. Tringali A, Blero D, Boskoski I, et al. Difficult removal of fully covered self expandable metal stents (SEMS) for benign biliary strictures: the "SEMS in SEMS" technique. Dig Liver Dis. 2014;46(6):568-571. Review/Other-Dx 5 patients To describe 5 cases in which FC-SEMS removal was challenge. The inner Fully Covered Self Expandable Metal Stent compressed the hyperplastic tissue, leading to the extraction of both the stents in all cases. Two complications were reported as a result of the attempt to stents removal (mild pancreatitis and self-limited haemobilia). 4
72. Huang T, Bass JA, Williams RD. The significance of biliary pressure in cholangitis. Arch Surg. 1969;98(5):629-632. Review/Other-Dx N/A To determine the significance of biliary pressure in initiating the process of biliary regurgitation of bacteria through an investigation in animals with cholangitis. No results stated in abstract. 4
73. Mayumi T, Okamoto K, Takada T, et al. Tokyo Guidelines 2018: management bundles for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018;25(1):96-100. Review/Other-Tx N/A To redefine the management bundles for acute cholangitis and cholecystitis in the Tokyo Guidelines 2013 (TG13) . Critical parts of the bundles in TG18 include the diagnostic process, severity assessment, transfer of patients if necessary, and therapeutic approach at each time point. Observance of these items and procedures should improve the prognosis of acute cholangitis and cholecystitis. 4
74. Gomi H, Takada T, Hwang TL, et al. Updated comprehensive epidemiology, microbiology, and outcomes among patients with acute cholangitis. J Hepatobiliary Pancreat Sci. 2017;24(6):310-318. Review/Other-Tx 7,294 patients To investigate updated epidemiology and outcomes among patients with acute cholangitis on a larger scale than the international practice guidelines for patients with acute cholangitis and cholecystitis were released in 2007 (TG07) and revised in 2013 (TG13), for the first time. The severity distribution was Grade I (37.5%), Grade II (36.2%), and Grade III (26.2%). The 30-day all-cause mortality was 2.4%, 4.7%, and 8.4% in Grade I, II, III severity, respectively (P < 0.001). The incidence of liver abscess and endocarditis as complications of acute cholangitis was 2.0% and 0.26%, respectively. 4
75. Boey JH, Way LW. Acute cholangitis. Ann Surg. 1980;191(3):264-270. Review/Other-Tx 99 patients To analyze the features of cholangitis in 99 consecutive cases, treated in the last ten years. The disease was severe and refractory in half the cases due to malignant stricture, and in 20% of those due to gallstones. Benign strictures, sclerosing cholangitis, and most cases of choledocholithiasis were associated with less severe cholangitis, which responded promptly to antibiotic therapy. High fever, a serum bilirubin level above 4 mg/dl, and hypotension characterized the most severe refractory cases in which emergency surgery was mandatory. Patients without manifestations were nearly always controlled successfully with antibiotics. 4
76. van den Hazel SJ, Speelman P, Tytgat GN, Dankert J, van Leeuwen DJ. Role of antibiotics in the treatment and prevention of acute and recurrent cholangitis. Clin Infect Dis. 1994;19(2):279-286. Review/Other-Tx N/A To review the use of antibiotics for treatment, prophylaxis, and maintenance therapy to control cholangitis. Antibiotic prophylaxis for cholangitis ought to be given as a single (high) dose shortly before surgical or nonsurgical manipulations of the biliary system. Patients with a compromised biliary system (e.g., on account of an endoprosthesis in situ or hepaticojejunostomy) who are prone to develop recurrent bouts of cholangitis may benefit from antibiotic maintenance therapy, given daily in lower-than-therapeutic dosages. 4
77. Kiriyama S, Takada T, Hwang TL, et al. Clinical application and verification of the TG13 diagnostic and severity grading criteria for acute cholangitis: an international multicenter observational study. J Hepatobiliary Pancreat Sci. 2017;24(6):329-337. Review/Other-Dx 6,063 patients To verify the efficacy of the TG13 Tokyo Guidelines (TG13), which have been widely adopted throughout the world as global standards, through our international multicenter study. A diagnosis of acute cholangitis was made in 5,454 (90.0%) patients on the basis of the TG13 criteria, and in 4,815 (79.4%) patients on the basis of the TG07 criteria. The 30-day mortality rates of patients with Grade III, Grade II, and Grade I were 5.1%, 2.6%, and 1.2%, respectively, and increased significantly along with disease severity. The mortality rate in the 1,272 Grade II cases where urgent or early biliary drainage was performed was 2.0% (n = 25), which was significantly lower than that of 3.7% (n = 28) in the other 748 cases. 4
78. Park CS, Jeong HS, Kim KB, et al. Urgent ERCP for acute cholangitis reduces mortality and hospital stay in elderly and very elderly patients. Hepatobiliary Pancreat Dis Int. 15(6):619-625, 2016 Dec. Review/Other-Tx 331 patients To evaluate the effects of methods and timing of biliary drainage on the outcomes of acute cholangitis in elderly and very elderly patients. Acute cholangitis in older patients manifested as atypical symptoms characterized as infrequent Charcot's triad (4.2%) and comorbidity in one-third of the patients. Patients were graded as mild, moderate, and severe cholangitis in 104 (31.4%), 175 (52.9%), and 52 (15.7%), respectively. Urgent biliary drainage (</=24 hours) was performed for 80.5% (247/307) of patients. Very elderly patients tended to have more severe grades and were treated with sequential procedures of transient biliary drainage and stone removal at different sessions. Hospital stay was related to methods and timing of biliary drainage. Mortality was very low (1.5%) and not related to patient age but rather to the success or failure of biliary drainage and severity grading of the acute cholangitis. 4
79. Lai EC, Chu KM, Lo CY, Fan ST, Lo CM, Wong J. Choice of palliation for malignant hilar biliary obstruction. Am J Surg. 1992;163(2):208-212. Observational-Tx 50 patients To aid in the selection of appropriate palliative measures, clinical data from 50 consecutive patients with unresectable hilar tumors situated at or proximal to the common hepatic duct, were retrospectively analyzed. Thirty-four patients had cholangioenteric bypass (CEB) to either left (28 patients), right (3 patients), or both (3 patients) intrahepatic ductal systems. Sixteen patients had nonoperative drainage (NOD) established either endoscopically (4 patients), percutaneously (9 patients), or using a combined endoscopic-percutaneous approach (3 patients). While comparable postprocedural complications (13 CEB patients versus 4 NOD patients) were observed, patients with NOD had a significantly higher hospital mortality (9 CEB patients versus 9 NOD patients, p less than 0.05). Excluding the 12 patients (6 CEB patients versus 6 NOD patients) who died within 30 days after drainage, the quality of survival of the remaining 38 patients was analyzed with reference to 6 objective parameters. Although patients with NOD had significantly more frequent admissions relating to their catheters (p less than 0.02), there was no qualitative difference in the survival rate between the two groups of patients. 3
80. Sugiyama M, Atomi Y. Treatment of acute cholangitis due to choledocholithiasis in elderly and younger patients. Arch Surg. 1997;132(10):1129-1133. Review/Other-Tx 191 patients To evaluate management strategies for acute cholangitis in elderly patients (age, > or = 80 years). The elderly patients had higher incidences of septic shock or mental confusion (acute severe cholangitis)(43.2%) and concomitant diseases (81.1%) than the younger patients (25.3% and 42.9%, respectively). The elderly patients had significantly greater morbidity (37.8%) and mortality (10.8%), compared with the younger patients (16.9% and 3.2%, respectively). Mortality was 18.8% in elderly patients with severe cholangitis and 4.8% in those with nonsevere cholangitis. In the elderly patients, endoscopic drainage yielded lower morbidity (16.7%) and mortality (5.6%) than surgical (87.5% and 25.0%, respectively) and percutaneous drainage (36.4% and 9.1%, respectively). No complications occurred after endoscopic nasobiliary drainage without sphincterotomy. 4
81. Mukai S, Itoi T, Baron TH, et al. Indications and techniques of biliary drainage for acute cholangitis in updated Tokyo Guidelines 2018. J Hepatobiliary Pancreat Sci. 2017:[E-pub ahead of print]. Experimental-Tx 60 patients To compare the efficacy of plastic tube stents (PSs) and self-expandable metallic stents (SEMSs) for unresectable malignant hilar biliary strictures. The 6-month patency rate was significantly higher in the SEMS group than in the PS group (81 vs. 20%; p = 0.0012). Kaplan-Meier analysis showed significantly longer patency in the SEMS group than in the PS group (p = 0.0002); the 50% patency period was 359 days in the SEMS group and 112 days in the PS group. There was no significant difference in the overall survival period between the PS and SEMS groups (p = 0.2834). The mean number of reinterventions for stent failures was significantly lower in the SEMS group (0.63 times/patient) than in the PS group (1.80 times/patient) (p = 0.0008). The overall total cost for the treatment was significantly lower in the SEMS group than in the PS group (p = 0.0222). 1
82. Andriulli A, Loperfido S, Napolitano G, et al. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007;102(8):1781-1788. Meta-analysis 12 studies; 16855 patients To provide health-care providers, patients, and physicians with an exhaustive assessment of prospective studies on rates of complications and fatalities associated with endoscopic retrograde cholangiopancreatography (ERCP). In 21 selected surveys, involving 16,855 patients, ERCP-attributable complications totaled 1,154 (6.85%, CI 6.46-7.24%), with 55 fatalities (0.33%, CI 0.24-0.42%). Mild-to-moderate events occurred in 872 patients (5.17%, CI 4.83-5.51%), and severe events in 282 (1.67%, CI 1.47-1.87%). Pancreatitis occurred in 585 subjects (3.47%, CI 3.19-3.75%), infections in 242 (1.44%, CI 1.26-1.62%), bleeding in 226 (1.34%, CI 1.16-1.52%), and perforations in 101 (0.60%, CI 0.48-0.72%). Cardiovascular and/or analgesia-related complications amounted to 173 (1.33%, CI 1.13-1.53%), with 9 fatalities (0.07%, CI 0.02-0.12%). As compared with old reports, morbidity rates increased significantly in most recent studies: 6.27%versus 7.51% (P(c)= 0.029). Good
83. Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 2009;70:80-8. Observational-Tx 11,497 procedures To determine predictors of post-ERCP (Endoscopic Retrograde Cholangiopancreatography) complications at our institution. There were 462 complications (4.0%), 42 of which were severe (0.36%) and 7 were fatal (0.06%). Specific complications of pancreatitis (2.6%) and bleeding (0.3%) were identified. Overall complications were statistically more likely among individuals with suspected sphincter of Oddi dysfunction (SOD) (odds ratio [OR] 1.91) and after a biliary sphincterotomy (OR 1.32). Subjects with a history of acute or chronic pancreatitis (OR 0.78) or who received a temporary small-caliber pancreatic stent (OR 0.69) had fewer complications. Post-ERCP pancreatitis was more likely to occur after a pancreatogram via the major papilla (OR 1.70) or minor papilla (OR 1.54) and among subjects with suspected SOD with stent placement (OR 1.45) or without stent placement (OR 1.84). Individuals undergoing biliary-stent exchange had less-frequent pancreatitis (OR 0.38). Biliary sphincterotomy was associated with bleeding (OR 4.71). Severe or fatal complications were associated with severe (OR 2.38) and incapacitating (OR 7.65) systemic disease, obesity (OR 5.18), known or suspected bile-duct stones (OR 4.08), pancreatic manometry (OR 3.57), and complex (grade 3) procedures (OR 2.86). 3
84. Masci E, Toti G, Mariani A, et al. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol 2001;96:417-23. Review/Other-Tx 2,423 patients: 2,444 procedures To investigate risk factors for complications of endoscopic retrograde cholangiopancreatography (ERCP/ES) in a prospective multicentric study. Overall complications occurred in 121 patients (4.95% of cases): pancreatitis in 44 patients (1.8%), hemorrhage in 30 (1.13%), cholangitis in 14 (0.57%), perforation during ES in 14 (0.57%), and others in 14 (0.57%); deaths occurred in three patients (0.12%). In multivariate analysis, the following were significant risk factors: a) for pancreatitis, age (< or = 60 yr), use of precutting technique, and failed clearing of biliary stones, and b) for hemorrhage, precut sphincterotomy and obstruction of the orifice of the papilla of Vater. 4
85. Kundu R, Pleskow D. Biliary and Pancreatic Stents: Complications and Management. Techniques in Gastrointestinal Endoscopy 2007;9:125-34. Review/Other-Tx N/A To examine the complications and management of biliary and pancreatic stents. No results stated in abstract. 4
86. Giovannini M, Moutardier V, Pesenti C, Bories E, Lelong B, Delpero JR. Endoscopic ultrasound-guided bilioduodenal anastomosis: a new technique for biliary drainage. Endoscopy. 2001;33(10):898-900. Review/Other-Tx 1 patient To present a new technique of biliary drainage using endoscopic ultrasound (EUS) and EUS-guided puncture of the common bile duct (CBD). The CBD was drained properly. No complication occurred. 4
87. Kahaleh M, Artifon EL, Perez-Miranda M, et al. Endoscopic ultrasonography guided biliary drainage: summary of consortium meeting, May 7th, 2011, Chicago. World J Gastroenterol. 2013;19(9):1372-1379. Review/Other-Dx N/A To summarize the agenda and conclusions of a meeting which covered improved EUS guided biliary access and drainage procedures, terminology, nomenclature, training and credentialing. No results stated in abstract. 4
88. Minaga K, Kitano M, Imai H, et al. Urgent endoscopic ultrasound-guided choledochoduodenostomy for acute obstructive suppurative cholangitis-induced sepsis. World J Gastroenterol. 2016;22(16):4264-4269. Review/Other-Tx 3 cases To describe three cases of successful biliary drainage with recovery from septic shock after urgent endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) was performed for AOSC due to biliary lithiasis. In all three cases, technical success in inserting the stents was achieved and the patients completely recovered from AOSC with sepsis in a few days after EUS-CDS. There were no procedure-related complications. 4
89. Kato H, Tsutsumi K, Kawamoto H, Okada H. Current status of endoscopic biliary drainage for unresectable malignant hilar biliary strictures. World J Gastrointest Endosc. 2015;7(11):1032-1038. Review/Other-Tx N/A To review the current literature concerning endoscopic biliary drainage for patients with UMHBS. No results stated in abstract. 4
90. Nam HS, Kang DH. Current Status of Biliary Metal Stents. Clin Endosc. 2016;49(2):124-130. Review/Other-Tx N/A To review the current guidelines for managing malignant and benign biliary obstructions and discuss recent developments in biliary stenting. No results stated in abstract. 4
91. Pisters PW, Hudec WA, Hess KR, et al. Effect of preoperative biliary decompression on pancreaticoduodenectomy-associated morbidity in 300 consecutive patients. Ann Surg. 2001;234(1):47-55. Observational-Tx 300 patients To examine the relationship between preoperative biliary drainage and the morbidity and mortality associated with pancreaticoduodenectomy. Preoperative prosthetic biliary drainage was performed in 172 patients (57%) (stent group), 35 patients (12%) underwent surgical biliary bypass performed during prereferral laparotomy, and the remaining 93 patients (31%) (no-stent group) did not undergo any form of preoperative biliary decompression. The overall surgical death rate was 1% (four patients); the number of deaths was too small for multivariate analysis. By multivariate logistic regression, no differences were found between the stent and no-stent groups in the incidence of all complications, major complications, infectious complications, intraabdominal abscess, or pancreaticojejunal anastomotic leak. Wound infections were more common in the stent group than the no-stent group. 3
92. Sohn TA, Yeo CJ, Cameron JL, Pitt HA, Lillemoe KD. Do preoperative biliary stents increase postpancreaticoduodenectomy complications? J Gastrointest Surg. 2000;4(3):258-267; discussion 267-258. Observational-Tx 567 patients To retrospectively review a prospectively collected database where patients undergoing preoperative biliary stenting were compared with patients who did not undergo stenting. Those who had stents placed were more likely to have jaundice (67% vs. 38%; P <0.0001) and fever (5% vs. 1%; P = 0.03) as presenting symptoms. There were no differences in multiple intraoperative parameters when the two groups were compared. Patients who had stents placed had a perioperative mortality rate of 1.7% compared to 2.5% in those who did not (P = 0.3). Although the overall complication rates were 35% in those who had stents placed and 30% in those who did not (P = NS), patients with stents experienced a significantly increased incidence of pancreatic fistula (10% vs. 4%; P = 0.02) and wound infection (10% vs. 4%; P = 0.02). The incidences of other postoperative complications were similar between the stented and unstented groups. Eight patients (3%) in the percutaneously stented group developed significant hemobilia after stent placement, whereas none of the patients undergoing endoscopic stent placement developed hemobilia (P = 0.03). There were no statistical differences in other complications between the percutaneously and endoscopically stented groups. Preoperative biliary stenting did not increase the overall complication rate or mortality rate in patients undergoing pancreaticoduodenectomy. 3
93. Lygidakis NJ, van der Heyde MN, Lubbers MJ. Evaluation of preoperative biliary drainage in the surgical management of pancreatic head carcinoma. Acta Chir Scand. 1987;153(11-12):665-668. Experimental-Dx 38 patients To evaluate preoperative biliary drainage in the surgical management of pancreatic head carcinoma. Two group B patients died of causes unrelated to absence of preoperative biliary drainage. In group B, however, the intrabiliary pressure was higher than in group A and was associated with heightened incidence of biliary infection, bacteremia and intraoperative bleeding. The intergroup difference in incidence of early complications was statistically significant. 1
94. Povoski SP, Karpeh MS, Jr., Conlon KC, Blumgart LH, Brennan MF. Association of preoperative biliary drainage with postoperative outcome following pancreaticoduodenectomy. Ann Surg. 1999;230(2):131-142. Observational-Tx 240 patients To determine whether preoperative biliary instrumentation and preoperative biliary drainage are associated with increased morbidity and mortality rates after pancreaticoduodenectomy. One hundred seventy-five patients (73%) underwent preoperative biliary instrumentation (endoscopic, percutaneous, or surgical instrumentation). One hundred twenty-six patients (53%) underwent preoperative biliary drainage (endoscopic stents, percutaneous drains/stents, or surgical drainage). The overall postoperative morbidity rate after pancreaticoduodenectomy was 48% (114/240). Infectious complications occurred in 34% (81/240) of patients. Intraabdominal abscess occurred in 14% (33/240) of patients. The postoperative mortality rate was 5% (12/240). Preoperative biliary drainage was determined to be the only statistically significant variable associated with complications (p = 0.025), infectious complications (p = 0.014), intraabdominal abscess (p = 0.022), and postoperative death (p = 0.037). Preoperative biliary instrumentation alone was not associated with complications, infectious complications, intraabdominal abscess, or postoperative death. 2
95. Mangiavillano B, Pagano N, Baron TH, Luigiano C. Outcome of stenting in biliary and pancreatic benign and malignant diseases: A comprehensive review. World J Gastroenterol. 2015;21(30):9038-9054. Review/Other-Tx N/A To cover the indications an outcome of the different types of stents currently used, techniques of placement, established and upcoming indications, and complications associated with stent use. No results stated in abstract. 4
96. Mukai T, Yasuda I, Nakashima M, et al. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013;20(2):214-222. Experimental-Tx 60 patients To compare the efficacy of PSs and SEMSs for unresectable malignant hilar biliary strictures. The 6-month patency rate was significantly higher in the SEMS group than in the PS group (81 vs. 20%; p = 0.0012). Kaplan-Meier analysis showed significantly longer patency in the SEMS group than in the PS group (p = 0.0002); the 50% patency period was 359 days in the SEMS group and 112 days in the PS group. There was no significant difference in the overall survival period between the PS and SEMS groups (p = 0.2834). The mean number of reinterventions for stent failures was significantly lower in the SEMS group (0.63 times/patient) than in the PS group (1.80 times/patient) (p = 0.0008). The overall total cost for the treatment was significantly lower in the SEMS group than in the PS group (p = 0.0222). 1
97. Lawrence C, Howell DA, Conklin DE, Stefan AM, Martin RF. Delayed pancreaticoduodenectomy for cancer patients with prior ERCP-placed, nonforeshortening, self-expanding metal stents: a positive outcome. Gastrointest Endosc. 2006;63(6):804-807. Review/Other-Dx 100 patients To quantitate the frequency with which patients diagnosed with unresectable pancreaticobiliary malignancy (and hence undergoing self-expanding metal stents (SEMS) placement) eventually undergo Whipple's resection, and to report on the outcomes in these patients. Despite apparent unresectability, 13 of 100 patients underwent delayed surgical exploration for an attempt at resection. Whipple's resection was successfully performed in 5 patients. No interference with the biliary anastomosis was noted. No unresectable patient required surgical biliary bypass because of the presence of the stent. No pre- or postoperative infections occurred. 4
98. Krokidis M, Fanelli F, Orgera G, et al. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. Cardiovasc Intervent Radiol 2011;34:352-61. Experimental-Tx 80 patients To compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Mean patency was 166.0 +/- 13.11 days for the bare-stent group and 234.0 +/- 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 +/- 22.5 days for the bare-stent group and 130.3 +/- 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 +/- 11.8 days for the bare-stent group and 247.0 +/- 20 days for the covered-stent group (p = 0.06). 1
99. Kullman E, Frozanpor F, Soderlund C, et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 2010;72:915-23. Experimental-Tx 400 patients To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). 1
100. Ginsberg G, Cope C, Shah J, et al. In vivo evaluation of a new bioabsorbable self-expanding biliary stent. Gastrointest Endosc. 2003;58(5):777-784. Review/Other-Tx 8 animals To evaluate a new bioabsorbable biliary stent(BioStent) in a porcine model. Stents were delivered without sphincterotomy and were deployed easily, accurately, and with good immediate stent expansion and radiographic visualization. On follow-up, all stents were fully expanded and serum bilirubin levels remained within the normal range. Although there was no clinical evidence of biliary obstruction, filling defects were common at cholangiography. On histopathologic evaluation, there was neither bile duct integration or proliferative change. 4
101. Hatzidakis A, Krokidis M, Kalbakis K, Romanos J, Petrakis I, Gourtsoyiannis N. ePTFE/FEP-covered metallic stents for palliation of malignant biliary disease: can tumor ingrowth be prevented? Cardiovasc Intervent Radiol. 2007;30(5):950-958. Experimental-Tx 36 patients To determine the application and clinical effectiveness of ePTFE/FEP-covered metallic stents for palliation of malignant biliary disease, and to evaluate the efficiency of stent coverage in preventing tumor ingrowth. Thirty-seven covered stents were percutaneously implanted. The technical success rate was 97%. Reintervention was required in 6 cases. The 30-day mortality rate was 40%, not procedure-related. Mean survival was 128 days. Primary patency rates were 100%, 55.5%, and 25% at 3, 6, and 12 months, respectively, while the assisted patency rate was 100% at 12 months. Stents without side holes had higher primary patency rates compared with those with side holes, where occlusion was always due to tumor ingrowth. Tumor ingrowth did not occur in the completely covered stents. No stent dysfunction due to sludge incrustation was found. Complications were 1 case of arterial laceration that occurred during percutaneous transhepatic cholangiography, and a subcapsular hematoma and 1 case of bile peritonitis, that both occurred during primary stenting. No complications followed the secondary stenting technique. 3
102. Schoder M, Rossi P, Uflacker R, et al. Malignant biliary obstruction: treatment with ePTFE-FEP- covered endoprostheses initial technical and clinical experiences in a multicenter trial. Radiology. 2002;225(1):35-42. Experimental-Tx 42 patients To determine and present the initial technical and clinical results of using an expanded polytetrafluoroethylene-fluorinated ethylene propylene (ePTFE-FEP)-covered biliary endoprosthesis to treat malignant biliary obstruction. Successful deployment, correct positioning, and patency of the device were achieved in all patients. Procedure-related complications occurred in two (5%) patients. Thirty-day mortality rate was 20% (eight of 41 patients), and median survival time was 146 days. Laboratory values decreased significantly after the procedure (P <.001). Recurrent obstructive jaundice occurred in six (15%) patients. Primary patency rates at 3, 6, and 12 months were 90%, 76%, and 76%, respectively. Calculation of the composite end point of death or obstruction revealed a median patency duration of 138 days. No endoprosthesis migration was observed. Branch duct obstruction was observed in four (10%) patients. Postmortem examination of one stent revealed a widely patent endoprosthesis with intact covering. 3
103. Suk KT, Kim JW, Kim HS, et al. Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction: multicenter pilot study. Gastrointest Endosc. 2007;66(4):798-803. Experimental-Tx 21 patients To evaluate the safety and efficacy of an MSCPM for patients with malignant biliary obstruction. Occlusion of the MSCPM was observed in 9 patients and was caused by bile sludge or clog in 4, tumor overgrowth in 3, and tumor ingrowth in 2. Complications included obstructive jaundice in 6, cholangitis in 3, and 1 patient showed stent migration with cholecystitis. The mean patency of a MSCPM was 429 days (median 270 days, range 68-810 days) and cumulative patency rates at 3, 6, and 12 months were 100%, 71%, and 36%, respectively. The mean survival of patients was 350 days (median 281 days, range 68-811 days). The highest concentration of paclitaxel in the blood was found between 1 and 10 days after insertion. 3
104. Park DH, Jang JW, Lee SS, Seo DW, Lee SK, Kim MH. EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results. Gastrointest Endosc. 2011;74(6):1276-1284. Observational-Tx 57 patients To evaluate risk factors for adverse events and long-term outcomes of EUS-BDS. The overall technical and functional success rates, respectively, in the EUS-BDS group were 96.5% (intention-to-treat, n = 55/57) and 89% (per-protocol, n = 49/55). Postprocedure adverse events developed after EUS-BDS in 11 patients (20%, n = 11/55). This included bile peritonitis (n = 2), mild bleeding (n = 2), and self-limited pneumoperitoneum (n = 7). In multivariate analysis, needle-knife use was the single risk factor for postprocedure adverse events after EUS-BDS (odds ratio 12.4; P = .01). A late adverse event in EUS-BDS was distal stent migration (7%, n = 4/55). The mean stent patencies with EUS-HGS and EUS-CDS were 132 days and 152 days, respectively. 3
105. Park DH, Jeong SU, Lee BU, et al. Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video). Gastrointest Endosc. 2013;78(1):91-101. Observational-Tx 45 patients To evaluate our treatment algorithm for guidewire manipulation protocol for EUS-BD after failed ERCP. The overall technical and functional success rates of EUS-BD in this study were 91% (intention to treat, n = 41/45) and 95% (per protocol, n = 39/41), respectively. Specifically, rendezvous (n = 20) and antegrade therapy (n = 14) were initially feasible in 34 of 45 patients (76%). With our protocol, 25 of 45 patients (56%) were eventually treated with rendezvous and antegrade therapy as a first-line or crossover treatment. EUS-guided biliary drainage with transluminal stenting in patients with duodenal invasion or failed antegrade therapy was feasible in the remaining 20 patients (44%). The overall adverse event rate of EUS-BD was 11%. 2
106. Vila JJ, Perez-Miranda M, Vazquez-Sequeiros E, et al. Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey. Gastrointest Endosc. 2012;76(6):1133-1141. Observational-Tx 125 patients To evaluate outcomes of endoscopic ultrasound (EUS)-guided cholangiopancreatography (ESCP) in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist. A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula. 3
107. Artifon EL, Aparicio D, Paione JB, et al. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol. 2012;46(9):768-774. Experimental-Tx 25 subjects To prospectively compare EUS-CD and PTBD in patients with unresectable malignant biliary obstruction. Twenty-five subjects were randomized (13 EUS-CD and 12 PTBD). Mean age was 67 years (SD, 11.9). The 2 groups were similar before intervention in terms of quality of life [EUS-CD (58.3) vs. PTBD (57.8); P=0.78], total bilirubin (16.4 vs. 17.2; P=0.7), alkaline phosphatase (539 vs. 518; P=0.7), and gamma-glutamyl transferase (554.3 vs. 743.5; P=0.56). All procedures were technically and clinically successful in both groups. At 7-day follow-up there was a significant reduction in total bilirubin in both the groups (EUS-CD, 16.4 to 3.3; P=0.002 and PTBD, 17.2 to 3.8; P=0.01), although no difference was noted comparing the 2 groups (EUS-CD to PTBD; 3.3 vs. 3.8; P=0.2). There was no difference between the complication rates in the 2 groups (P=0.44), EUS-CD (2/13; 15.3%) and PTBD (3/12; 25%). Costs were similar in the 2 groups also ($5673-EUS-CD vs. $7570-PTBD; P=0.39). 1
108. Shah JN, Marson F, Weilert F, et al. Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc. 2012;75(1):56-64. Observational-Tx 95 patients To report a large experience with endoscopic ultrasound (EUS)-guided anterograde cholangiopancreatography (EACP) to facilitate ductal access or perform direct EUS-guided therapy in patients with postsurgical anatomy or failed endoscopic reterograde cholangiopancreatography (ERCP). EACP procedures were attempted in 95 of 2566 ERCP procedures (3.7%). EUS-guided cholangiography (n = 70) and pancreatography (n = 25) were successful in 97% and 100%, respectively. EUS-guided rendezvous ERCP was successful in 75% of biliary procedures and in 56% of pancreatic procedures. Direct EUS-guided therapy was successful in 86% and 75% of biliary and pancreatic procedures, respectively. Direct interventions included pancreaticogastrostomy (n = 10), anterograde stent across stricture (n = 10), hepaticogastrostomy (n = 8), and choledochoduodenostomy (n = 1). Ten complications (10.5%) related to EACP or subsequent rendezvous ERCP included pancreatitis (n = 5), hematoma (n = 1), bile leak (n = 1), bacteremia (n = 1), pneumoperitoneum (n = 1), and perforation (n = 1). 3
109. Leng JJ, Zhang N, Dong JH. Percutaneous transhepatic and endoscopic biliary drainage for malignant biliary tract obstruction: a meta-analysis. World J Surg Oncol. 2014;12(1):272. Meta-analysis 184 patients; 3 studies To conduct a meta-analysis to compare the effectiveness and safety of endoscopic biliary drainage (EBD) and percutaneous transhepatic biliary drainage (PTBD). Our analysis showed no significant difference in restoration of bile flow between patients treated with EBD and those treated with PTBD (odds ratio (OR) = 2.34, 95% confidence interval (CI) = 0.32 to 17.16, P = 0.401).However, the result of sensitivity analysis indicated that the study conducted by Speer et al. influenced the pooled estimates. After the Speer et al. study was excluded, the therapeutic success rate of patients treated with PTBD was significantly greater than that of those who underwent EBD (OR = 5.48, 95% CI: 2.26 to 13.28, P < 0.001). The 30-day mortality and complication rates were similar in the EBD and PTBD groups. Good
110. Briggs CD, Irving GR, Cresswell A, et al. Percutaneous transhepatic insertion of self-expanding short metal stents for biliary obstruction before resection of pancreatic or duodenal malignancy proves to be safe and effective. Surg Endosc. 2010;24(3):567-571. Observational-Tx 67 patients To retrospectively analyze the authors' prospective database containing all patients presenting with periampullary and pancreatic tumors between January 2004 and May 2008. The authors have attempted percutaneous placement of internal metal stents in 67 patients with resectable malignancies and biliary obstruction. Stenting was successful for 53 patients (79%), and 5 patients (9.4%) experienced complications. These five patients were successfully managed conservatively, and all proceeded to trial dissection. The mean bilirubin level was 253 mg/dl before intervention and 33 mg/dl before surgery for the stented patients compared with 308 mg/dl before intervention and 102 mg/dl before surgery for those who needed external drainage. 3
111. Mahgerefteh S, Hubert A, Klimov A, Bloom AI. Clinical Impact of Percutaneous Transhepatic Insertion of Metal Biliary Endoprostheses for Palliation of Jaundice and Facilitation of Chemotherapy. Am J Clin Oncol. 2015;38(5):489-494. Observational-Tx 29 patients To describe the technique and report on the clinical benefit of percutaneous transhepatic metal biliary endoprosthesis (TMBE) placement for the palliation of malignant biliary obstruction (MBO). All TMBE procedures were successful with no major procedure-related complications, and all patients improved clinically. Mean preprocedural and postprocedural bilirubin concentrations were 228.9+/-138.4 and 39.9.0+/-33.6 mumol/L, respectively (P<0.0001). Mean overall survival and occlusion-free survival were 9.355+/-2.425 months (95% confidence interval [4.60-14.12]) and 4.678+/-0.720 months (95% confidence interval [3.27-6.09]), respectively. Chemotherapy was initiated or reinstated in 16 patients (55%), 7 of whom (44%) demonstrated stable disease or partial response. Three patients were lost to follow-up. 3
112. Pinol V, Castells A, Bordas JM, et al. Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial. Radiology. 2002;225(1):27-34. Observational-Tx 54 patients To compare percutaneous self-expanding metal stents with conventional endoscopic polyethylene endoprostheses for treatment of malignant biliary obstruction by means of a prospective randomized clinical trial. After randomization, 28 patients were assigned to receive a percutaneous self-expanding metal stent and 26 patients to receive a 12-F endoscopic polyethylene prosthesis. The technical success rates of both implantation procedures were similar (percutaneous, 75% [21 of 28 patients]; endoscopic, 58% [15 of 26 patients]; P =.29), whereas therapeutic success was higher in the percutaneous group (71% [20 of 28 patients] vs 42% [11 of 26 patients]; P =.03). However, major complications were more common in the percutaneous group (61% [17 of 28 patients] vs 35% [nine of 26 patients]; P =.09) but did not account for differences in 30-day mortality rates (percutaneous, 36% [10 of 28 patients]; endoscopic, 42% [11 of 26 patients]; P =.83). Overall median survival was significantly higher in the percutaneous group than in the endoscopic group (3.7 vs 2.0 months; P =.02). Cox regression analysis enabled identification of placement of the percutaneous self-expanding metal stent as the only independent predictor of survival (relative risk, 2.19; 95% CI: 1.11, 4.31; P =.02). 1
113. Distler M, Kersting S, Ruckert F, et al. Palliative treatment of obstructive jaundice in patients with carcinoma of the pancreatic head or distal biliary tree. Endoscopic stent placement vs. hepaticojejunostomy. JOP. 2010;11(6):568-574. Observational-Tx 342 patients To determine if surgical or non-surgical management was the most appropriate therapy for the treatment of obstructive jaundice in the palliative setting. Two hundred and sixty-one (76%) patients showed obstructive jaundice. Mortality in Groups 1, 2, and 3 was 2.2%, 0%, and 2.4%, respectively and morbidity was 5.1%, 17.6%, and 14.6%, respectively. The mean interval between stent exchanges was 70.8 days. Median survival for patients treated only with an endoscopic stent (Group 1) was significantly shorter than that of patients who were first stented and subsequently treated with hepaticojejunostomy (Group 2) (5.1 vs. 9.4 months; P<0.001). 2
114. Smigielski J, Holynski J, Kococik M, et al. [Paliative procedures in cholangiocarcinomas--experience of 5 centers]. Pol Merkur Lekarski. 2009;26(155):416-419. Observational-Tx 430 patients To evaluate some therapeutic methods in paliative treatment applied in patients with biliary tract cancer. G1 techniques were applied in 75 patients, G2 in 14 cases and G3 in 74 cases. In the last group of patients the following procedures have been performed: triple bypass (TB) in 45 cases (62%), choledochoduodenostomy (ChD) in 7 cases (9%), gastroenterostomy (GE) in 10 patients (13%) and laparotomy with Kehr drainage in 12 patients (16%). The number of complications in G1 group was observed in 31%, in G2--42%, and in G3--63%. 30 days death rate was 14% in G1, 28% in G2 and 18% in G3. Over 12 months survival rate was in G1, 3 months in G2 and 15 months in G3. Differences are statistically sagnificant (p < 0.05). 2
115. Alves de Lima SL, Bustamante FAC, Houmeaux de Moura EG, et al. Endoscopic palliative treatment versus surgical bypass in malignant low bile duct obstruction: A systematic review and meta-analysis. Int J Hepatobiliary Pancreat Dis. 2015;5:35-45. Meta-analysis 12 studies To acquire and analyze data to compare the success of procedures, procedure-related complication, mortality in 30 days, recurrent-jaundice rates in endoscopic, and surgical palliative techniques. No differences were observed for success of procedures; differences were observed with better outcomes for endoscopy therapy with regards to mortality associated with procedure, complication associated with procedure, and mortality in 30 days. Also, differences were observed with better outcomes for surgery therapy for recurrent-jaundice. Good
116. House MG, Cameron JL, Schulick RD, et al. Incidence and outcome of biliary strictures after pancreaticoduodenectomy. Ann Surg 2006;243:571-6; discussion 76-8. Review/Other-Tx 1595 patients To examine the incidence of biliary stricture formation after pancreaticoduodenectomy (PD) for benign and malignant periampullary disease. Forty-two of the 1595 patients (2.6%) who underwent PD developed postoperative jaundice secondary to a stricture of the biliary-enteric anastomosis. There was no difference in the incidence of biliary strictures after resection for benign (n = 10, 2.6%) or malignant disease (n = 32, 2.6%). The median time to stricture formation resulting in jaundice was 13 months (range, 1-106 months) and was similar for patients with benign and malignant disease. Preoperative jaundice did not protect against biliary stricture formation. By univariate analysis, biliary strictures were associated with preoperative percutaneous biliary drainage (odds ratio [OR] = 2.11, P = 0.02) and postoperative biliary stenting (OR = 2.11, P = 0.013). Postoperative chemoradiotherapy in patients with malignant disease was not associated with stricture formation. All strictures were initially managed with percutaneous biliary balloon dilatation and stenting, and only 2 patients required redo hepaticojejunostomy. Recurrent neoplastic disease was discovered in only 3 of the 32 patients (9%) with malignant disease. All 3 of these patients had cholangiocarcinoma as their initial diagnosis. 4
117. Seyama Y, Makuuchi M. Current surgical treatment for bile duct cancer. World J Gastroenterol. 2007;13(10):1505-1515. Review/Other-Tx N/A To review the current treatment of extrahepatic bile duct cancer and elucidate safe and beneficial surgical treatments and the surgeon’s role in treatment. No results stated in abstract. 4
118. Silva MA, Tekin K, Aytekin F, Bramhall SR, Buckels JA, Mirza DF. Surgery for hilar cholangiocarcinoma; a 10 year experience of a tertiary referral centre in the UK. Eur J Surg Oncol. 2005;31(5):533-539. Observational-Tx 174 patients To review the outcome of patients operated for hilar cholangiocarcinoma and analyse prognostic variables. Endoscopic retrograde cholangiopancreatography (ERCP) was the initial interventional investigation at the referring centre in 150, of which only 30 were stented successfully. PTC and decompression was carried out on 120. In 17, combined PTC and ERCP were required for placement of stents. Seventy-two underwent laparotomy at which 27 had locally advanced disease. Forty-five had potentially curative resections. Extra hepatic bile duct resection was done in 14 patients of which four were R0 resections. Thirty-one had bile duct resection including partial hepatectomy with 19 R0 resections (P=0.042). Post-operative complications developed in 19 patients, and there were 4 30 day mortalities [hepatic insufficiency:/sepsis (n=3), thrombosis of the reconstructed portal vein (n=1)]. Among the patients with R0 resections, the cumulative survival rates at 1, 3, and 5 year; was 83, 58, 41%, respectively, and in those with R1 resections were 71, 24, 24%, respectively, (P=0.021). Overall survival was shorter in patients with positive perineural invasion (P=0.066: NS). There was no significant difference in survival between the node positive and negative group. Median survival of patients who underwent liver resection was longer than those with bile duct resection only (30 vs 24 months P=0.43: NS). 2
119. Kloek JJ, van der Gaag NA, Aziz Y, et al. Endoscopic and percutaneous preoperative biliary drainage in patients with suspected hilar cholangiocarcinoma. J Gastrointest Surg. 2010;14(1):119-125. Observational-Tx 115 patients To compare outcomes of endoscopic biliary drainage (EBD) and percutaneous transhepatic biliary drainage (PTBD) in patients with resectable hilar cholangiocarcinoma (HCCA). Of these patients, 101 (88%) underwent PBD; 90 patients underwent EBD as primary procedure, and 11 PTBD. The technical success rate of initial drainage was 81% in the EBD versus 100% in the PTBD group (P = 0.20). Stent dislocation was similar in the EBD and PTBD groups (23% vs. 20%, P = 0.70). Infectious complications were significantly more common in the endoscopic group (48% vs. 9%, P < 0.05). Patients in the EBD group underwent more drainage procedures (2.8 vs. 1.4, P < 0.01) and had a significantly longer drainage period until laparotomy (mean 15 weeks vs. 11 weeks in the PTBD group; P < 0.05). In 30 patients, EBD was converted to PTBD due to failure of the endoscopic approach. 2
120. Saluja SS, Gulati M, Garg PK, et al. Endoscopic or percutaneous biliary drainage for gallbladder cancer: a randomized trial and quality of life assessment. Clin Gastroenterol Hepatol. 2008;6(8):944-950 e943. Experimental-Tx 54 patients To compare unilateral PTBD and ES in patients with a hilar block caused by GBC and assess their quality of life (QOL). Fifty-four patients were randomized to PTBD or ES (27 each). Successful drainage was better in the PTBD group (89% vs 41%; P < .001). Early cholangitis was significantly higher in the ES group (48% vs 11%; P = .002). Procedure-related (4% vs 8%) and 30-day mortality (4% vs 8%) and median survival were similar (60 days in both; P = .71). Although the World Health Organization-Quality of Life 1- and 3-month physical and psychological scores were better after PTBD, the difference was not significant. The European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire 30 global health status at 3 months was significantly better after PTBD (75 vs 30.5, P = .02). The EORTC symptom scores improved in both groups, but only fatigue was significantly better after PTBD. 1
121. Paik WH, Park YS, Hwang JH, et al. Palliative treatment with self-expandable metallic stents in patients with advanced type III or IV hilar cholangiocarcinoma: a percutaneous versus endoscopic approach. Gastrointest Endosc. 2009;69(1):55-62. Observational-Tx 85 patients To compare the clinical outcomes of endoscopic biliary drainage and percutaneous biliary drainage in patients. Baseline characteristics were similar in the 2 groups, but the rate of successful biliary decompression was significantly higher in the percutaneous self-expandable metallic stents (SEMS) group than in the endoscopic SEMS group (92.7% vs 77.3%, respectively, P= .049). Overall rates of procedure-related complications were similar for the 2 groups, but 1 death (from biliary sepsis) occurred in the endoscopic SEMS group. Median survival of patients in whom biliary drainage was successful initially, regardless of which procedure was performed, was much longer than that of patients who had failed biliary drainage (8.7 months vs 1.8 months, respectively, P< .001). Once successful biliary decompression had been achieved, median survival and stent patency duration were similar in the 2 study groups. 2
122. Mansfield SD, Barakat O, Charnley RM, et al. Management of hilar cholangiocarcinoma in the North of England: pathology, treatment, and outcome. World J Gastroenterol. 2005;11(48):7625-7630. Observational-Tx 75 patients To assess the management and outcome of hilar cholangiocarcinoma (Klatskin tumor) in a single tertiary referral center. Seventy-five patients were identified. The median age was 64 years (range 34-84 years). Male to female ratio was 1:1. Eighty-nine percent of patients presented with jaundice. Most patients referred were under Bismuth classification 3a, 3b or 4. Seventy patients required biliary drainage, 65 patients required 152 percutaneous drainage procedures, and 25 had other complications. Forty-one patients had 51 endoscopic drainage procedures performed (15 failed). Of these, 36 subsequently required percutaneous drainage. The median number of drainage procedures for all patients was three, 18 patients underwent resection (24%), nine had major complications and three died post-operatively. The 5-year survival rate was 4.2% for all patients, 21% for resected patients and 0% for those who did not undergo resection (P = 0.0021). The median number of admissions after diagnosis in resected patients was two and three in non-resected patients (P<0.05). Twelve patients had external-beam radiotherapy, seven brachytherapy, and eight chemotherapy. There was no significant benefit in terms of survival (P = 0.46) or hospital admissions. 3
123. Fabbri C, Luigiano C, Lisotti A, et al. Endoscopic ultrasound-guided treatments: are we getting evidence based--a systematic review. World J Gastroenterol. 2014;20(26):8424-8448. Review/Other-Tx N/A To systematically review to record the entire body of literature accumulated over the past 2 decades on EUS-guided interventions with the objective of performing a critical appraisal of published articles, based on the classification of studies according to levels of evidence, in order to assess the scientific progress made in this field. No results stated in abstract. 4
124. Ogura T, Sano T, Onda S, et al. Endoscopic ultrasound-guided biliary drainage for right hepatic bile duct obstruction: novel technical tips. Endoscopy. 2015;47(1):72-75. Observational-Tx 11 patients To evaluate the technical feasibility and clinical efficacy of a novel technique of Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) for right isolated left intrahepatic bile duct (IHBD) obstruction. Mean procedure time was 33.9 +/- 10.0 minutes. Technical and functional success were achieved in all patients, and no adverse events occurred. 2
125. Park SJ, Choi JH, Park DH, et al. Expanding indication: EUS-guided hepaticoduodenostomy for isolated right intrahepatic duct obstruction (with video). Gastrointest Endosc. 2013;78(2):374-380. Review/Other-Dx 6 patients To evaluate the technical feasibility and safety of EUS-guided hepaticoduodenostomy (EUS-HD) in cases of isolated right IHD obstruction. No results stated in abstract. 4
126. Prachayakul V, Aswakul P. Endoscopic ultrasound-guided biliary drainage: Bilateral systems drainage via left duct approach. World J Gastroenterol. 2015;21(34):10045-10048. Review/Other-Tx 1 patient To present the case of a 77-year-old man with advanced hilar cholangiocarcinoma who had undergone a roux-en-Y hepaticojejunostomy several months prior. No results stated in abstract. 4
127. Papadopoulos V, Filippou D, Manolis E, Mimidis K. Haemostasis impairment in patients with obstructive jaundice. J Gastrointestin Liver Dis. 2007;16(2):177-186. Review/Other-Tx N/A To review the haemostasis impairment in obstructive jaundice with special reference to the hepatic cirrhosis and failure, to systemic inflammation and sepsis that develops in cholestatic diseases, and finally in some other benign or malignant diseases including pancreatic adenocarcinoma, acute pancreatitis, cholangiocarcinoma, and hepatocellular carcinoma. No results stated in abstract. 4
128. Ferreira LE, Baron TH. Post-sphincterotomy bleeding: who, what, when, and how. Am J Gastroenterol. 2007;102(12):2850-2858. Review/Other-Tx N/A To review literature on post-ES bleeding. No results stated in abstract. 4
129. Saad WE, Wallace MJ, Wojak JC, Kundu S, Cardella JF. Quality improvement guidelines for percutaneous transhepatic cholangiography, biliary drainage, and percutaneous cholecystostomy. J Vasc Interv Radiol. 2010;21(6):789-795. Review/Other-Tx N/A To provide guidelines for percutaneous transhepatic cholangiography, biliary drainage, and percutaneous cholecystostomy. No results stated in abstract. 4
130. Tsauo J, Li X, Li H, et al. Transjugular insertion of bare-metal biliary stent for the treatment of distal malignant obstructive jaundice complicated by coagulopathy. Cardiovasc Intervent Radiol. 2013;36(2):521-525. Observational-Tx 6 patients To investigate retrospectively the feasibility of transjugular insertion of biliary stent (TIBS) for the treatment of distal malignant obstructive jaundice complicated by coagulopathy. The intrahepatic biliary tract was successfully accessed in all six patients via transjugular approach. The procedure was technically successfully in five of six patients, with a bare-metal stent implanted after traversing the biliary strictures. One procedure failed, because the guidewire could not traverse the biliary occlusion. One week after TIBS, the mean serum bilirubin in the five successful cases had decreased from 313 mumol/L (range 203.4-369.3) to 146.2 mumol/L (range 95.8-223.3) and had further decreased to 103.6 mumol/L (range 29.5-240.9) at 1 month after the procedure. No bleeding, sepsis, or other major complications were observed after the procedure. The mean survival of these five patients was 4.5 months (range 1.9-5.8). On imaging follow-up, there was no evidence of stent stenosis or migration, with 100 % primary patency. 3
131. Ring EJ, Kerlan RK, Jr. Interventional biliary radiology. AJR Am J Roentgenol. 1984;142(1):31-34. Review/Other-Tx N/A To review certain aspects of interventional biliary radiology and discuss expectations for future developments. No results stated in abstract. 4
132. Seif HM, Zidan M, Helmy A. One-stage percutaneous triple procedure for treatment of endoscopically unmanageable patients with malignant biliary obstruction and marked ascites. Arab J Gastroenterol. 2013;14(4):148-153. Observational-Tx 25 patients To assess the feasibility, safety and efficacy of one-stage percutaneous triple procedure including; ascites drainage, primary metallic biliary stenting, and tract embolisation with N-butyl 2-cyanoacrylate (NBCA), in treatment of patients with malignant biliary obstruction and marked ascites. The technical and clinical success rates were 96% and 88% respectively. No procedure related deaths or major complications were observed. The reported minor complications included; moderate pain and vomiting during and after balloon dilation, postprocedural cholangitis, and bile leakage in 44%, 16%, and 8% of the patients respectively. Primary stent patency was achieved in 96%. The 30-days mortality was 8%. The stent obstruction occurred in 3 (13%) of the 23 patients who survived more than 30-days. 3
133. Sofue K, Arai Y, Takeuchi Y, Fujiwara H, Tokue H, Sugimura K. Safety and efficacy of primary metallic biliary stent placement with tract embolization in patients with massive ascites: a retrospective analysis of 16 patients. J Vasc Interv Radiol. 2012;23(4):521-527. Observational-Tx 16 patients To evaluate the safety and efficacy of primary metallic biliary stent placement with tract embolization in patients with massive ascites. Stent placement and tract embolization were successful in all patients, without external drainage catheters left in place. Significant reduction of serum bilirubin level was observed in 14 patients (87.5%). No bile peritonitis or intraperitoneal hemorrhage occurred. Major complications included postprocedural cholangitis (12.5%), bloody bowel discharge (6.2%), and right pleural effusion (25.0%). One patient who died 19 days after intervention was deemed to represent a procedure-related mortality. During the survival period (range, 19-175 d; median, 66 d), stent occlusion was noted in two patients at 6 and 159 days after the procedure. Primary stent patency was achieved in 14 patients (87.5%). 2
134. Hara K, Yamao K, Mizuno N, et al. Endoscopic ultrasonography-guided biliary drainage: Who, when, which, and how? World J Gastroenterol. 2016;22(3):1297-1303. Review/Other-Tx N/A To discuss an EUS-BD algorithm for treatment of inoperable malignant lower biliary obstruction. No results stated in abstract. 4
135. Sharaiha RZ, Kumta NA, Desai AP, et al. Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography. Surg Endosc. 2016. Observational-Tx 60 patients To compare outcomes of EUS-BD and PTBD in patients with biliary obstruction at a single tertiary care center. A total of 60 patients were included (mean age 67.5 years, 65 % male). Forty-seven underwent EUS-BD, and thirteen underwent PTBD. Technical success rates of PTBD and EUS-BD were similar (91.6 vs. 93.3 %, p = 1.0). PTBD patients underwent significantly more re-interventions than EUS-BD patients (mean 4.9 versus 1.3, p < 0.0001), had more late (>24-h) adverse events (53.8 % vs. 6.6 %, p = 0.001) and experienced more pain (4.1 vs. 1.9, p = 0.016) post-procedure. In univariate analysis, clinical success was lower in the PTBD group (25 vs. 62.2 %, p = 0.03). In multivariable logistic regression analysis, EUS-BD was the sole predictor of clinical success and long-term resolution (OR 21.8, p = 0.009). 2