Multicenter retrospective and comparative study of 5-minute versus 15-second endoscopic papillary balloon dilation for removal of bile duct stones

Abstract

Background and study aims Endoscopic papillary balloon dilation (EPBD) is a method of bile duct stone removal that has a better long-term outcome but a high risk of post-ERCP pancreatitis (PEP). Recent studies have suggested that 5-minute EPBD can reduce the incidence of PEP. This study aimed to examine the safety and effectiveness of longer duration EPBD compared with shorter duration EPBD (5 minutes vs. 15 seconds after disappearance of the waist of a dilation catheter).

Patients and methods Patients without a history of endoscopic sphincterotomy or EPBD who underwent EPBD to remove bile duct stones were selected retrospectively from five centers. The incidence of PEP, other early adverse events, and outcomes of EPBD were compared between the groups. A multivariable analysis of risk factors for PEP was performed.

Results A total of 607 patients (157 and 450 in the 5-minute and 15-second EPBD groups, respectively) were included. There were no statistically significant differences between the groups in terms of the incidence of PEP (8.3 % and 8.9 % in the 5-minute and 15-second EPBD groups, respectively; P = 0.871) and the incidence of overall early adverse events (P = 0.999). Although 5-minute EPBD elongated the procedure time (45 vs. 37 minutes, P < 0.001), it increased the rate of complete stone removal during a single session (P < 0.001) and decreased the use of lithotripsy (P < 0.001).

Conclusions Compared with 15-second EPBD, 5-minute EPBD did not reduce the incidence of PEP.

• References

• 1 Vaira D, D’Anna L, Ainley C. Endoscopic sphincterotomy in 1000 consecutive patients. Lancet 1989; 19: 431-434
• 2 Freeman ML, Nelson DB, Sherman S. et al. Complications of endoscopic biliary sphincterotomy. NEJM 1996; 335: 909-918
• 3 Staritz M, Ewe K, Meyer zum Buschenfelde KH. Endoscopic papillary dilation (EPD) for the treatment of common bile duct stones and papillary stenosis. Endoscopy 1983; 15: 197-198
• 4 Minami A, Nakatsu T, Uchida N. et al. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci 1995; 40: 2550-2554
• 5 Bergman JJ, Rauws EA, Fockens P. et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. Lancet 1997; 349: 1124-1129
• 6 Ochi Y, Mukawa K, Kiyosawa K. Comparing the treatment outcomes of endoscopic papillary dilation and endoscopic sphincterotomy for removal of bile duct stones. J Gastroenterol Hepatol 1999; 14: 90-96
• 7 Fujita N, Maguchi H, Komatsu Y. et al. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003; 57: 151-155
• 8 Vlavianos P, Chopra K, Mandalia S. Endoscopic balloon dilatation versus endoscopic sphincterotomy for the removal of bile duct stones: a prospective randomised trial. Gut 2003; 52: 1165-1169
• 9 Disario JA, Freeman ML, Bjorkman DJ. et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004; 127: 1291-1299
• 10 Kawabe T, Komatsu Y, Tada M. et al. Endoscopic papillary balloon dilation in cirrhotic patients: removal of common bile duct stones without sphincterotomy. Endoscopy 1996; 28: 694-698
• 11 Takahara N, Isayama H, Sasaki T. et al. Endoscopic papillary balloon dilation for bile duct stones in patients on hemodialysis. J Gastroenterol 2012; 47: 918-923
• 12 Park DH, Kim M-H, Lee SK. et al. Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholithiasis in patients with liver cirrhosis and coagulopathy. Gastrointest Endosc 2004; 60: 180-185
• 13 Hamada T, Yasunaga H, Nakai Y. et al. Bleeding after endoscopic sphincterotomy or papillary balloon dilation among users of antithrombotic agents. Endoscopy 2015; 47: 997-1004
• 14 Yasuda I, Fujita N, Maguchi H. et al. Long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Gastrointest Endosc 2010; 72: 1185-1191
• 15 Doi S, Yasuda I, Mukai T. et al. Comparison of long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation: a propensity score-based cohort analysis. J Gastroenterol 2013; 48: 1090-1096
• 16 Kawabe T, Komatsu Y, Isayama H. et al. Histological analysis of the papilla after endoscopic papillary balloon dilation. Hepatogastroenterology 2003; 50: 919-923
• 17 Isayama H, Komatsu Y, Inoue Y. et al. Preserved function of the Oddi sphincter after endoscopic papillary balloon dilation. Hepatogastroenterology 2003; 50: 1787-1791
• 18 Yasuda I, Tomita E, Enya M. et al. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function?. Gut 2001; 49: 686-691
• 19 Liao WC, Tu YK, Wu MS. et al. Balloon dilation with adequate duration is safer than sphincterotomy for extracting bile duct stones: a systematic review and meta-analyses. Clin Gastroenterol Hepatol 2012; 10: 1101-1109
• 20 Liao WC, Lee CT, Chang CY. et al. Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc 2010; 72: 1154-1162
• 21 Komatsu Y, Kawabe T, Toda N. et al. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 226 cases. Endoscopy 1998; 30: 12-17
• 22 Tsujino T, Kawabe T, Isayama H. et al. Efficacy and safety of low-pressured and short-time dilation in endoscopic papillary balloon dilation for bile duct stone removal. J Gastroenterol Hepatol 2008; 23: 867-871
• 23 Tsujino T, Kawabe T, Komatsu Y. et al. Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients. Clin Gastroenterol Hepatol 2007; 5: 130-137
• 24 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 25 Kawakami H, Maguchi H, Mukai T. et al. A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study. Gastrointest Endosc 2012; 75: 362-372 , 372 e361
• 26 Akiyama D, Hamada T, Isayama H. et al. Superiority of 10-mm-wide balloon over 8-mm-wide balloon in papillary dilation for bile duct stones: A matched cohort study. Saudi J Gastroenterol 2015; 21: 213-219
• 27 Tsujino T, Isayama H, Komatsu Y. et al. Risk factors for pancreatitis in patients with common bile duct stones managed by endoscopic papillary balloon dilation. Am J Gastroenterol 2005; 100: 38-42
• 28 Freeman ML, DiSario JA, Nelson DB. et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-434
• 29 Ito K, Fujita N, Noda Y. et al. Can pancreatic duct stenting prevent post-ERCP pancreatitis in patients who undergo pancreatic duct guidewire placement for achieving selective biliary cannulation? A prospective randomized controlled trial. J Gastroenterol 2010; 45: 1183-1191
• 30 Nakai Y, Isayama H, Sasahira N. et al. Risk factors for post-ERCP pancreatitis in wire-guided cannulation for therapeutic biliary ERCP. Gastrointest Endosc 2015; 81: 119-126
• 31 Sasahira N, Kawakami H, Isayama H. et al. Early use of double-guidewire technique to facilitate selective bile duct cannulation: the multicenter randomized controlled EDUCATION trial. Endoscopy 2015; 47: 421-429
• 32 Choudhary A, Bechtold ML, Arif M. et al. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc 2011; 73: 275-282
• 33 Elmunzer BJ, Scheiman JM, Lehman GA. et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. NEJM 2012; 366: 1414-1422
• 34 Cheng CL, Sherman S, Watkins JL. et al. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol 2006; 101: 139-147
• 35 Levenick JM, Gordon SR, Fadden LL. et al. Rectal indomethacin does not prevent post-ERCP pancreatitis in consecutive patients. Gastroenterology 2016; 150: 911-917