RSS-Feed abonnieren
DOI: 10.1055/a-0639-5147
Comparison of endoscopic papillary large balloon dilation with or without endoscopic sphincterotomy for the treatment of large bile duct stones
TRIAL REGISTRATION: Multi-center, prospective, randomized controlled trial KCT0001564at https://cris.nih.go.kr/crisPublikationsverlauf
submitted 08. Januar 2018
accepted after revision 17. Mai 2018
Publikationsdatum:
03. Juli 2018 (online)
![](https://www.thieme-connect.de/media/endoscopy/201902/lookinside/thumbnails/16386_10-1055-a-0639-5147-1.jpg)
Abstract
Background Endoscopic papillary large balloon dilation (EPLBD) without prior endoscopic sphincterotomy (EST) produces excellent outcomes for the treatment of large common bile duct (CBD) stones. However, it remains unclear how the outcomes of EPLBD alone compare with those of EPLBD with EST. In this study, we assessed the safety and therapeutic outcomes of EPLBD with vs. without EST for the removal of large bile duct stones.
Methods This prospective, multicenter study was conducted on 200 patients with bile duct stones of ≥ 10 mm in diameter. Patients were randomly assigned to an EPLBD alone group (n = 100) or an EPLBD with EST group (n = 100). These two groups were compared with respect to overall procedure-related adverse events, overall stone removal success rate, number of endoscopic sessions required for complete stone removal, need for mechanical lithotripsy, and total procedure time.
Results The incidence of adverse events was not significantly different between the groups (EPLBD alone vs. EPLBD with EST: overall adverse events 6 % vs. 4 %, P = 0.75; pancreatitis 1 % vs. 3 %, P = 0.62). Overall success (P = 0.35), initial success (P = 0.28), and the need for mechanical lithotripsy (P = 0.39) were also similar between groups. Median total procedure time tended to be greater in the EPLBD alone group (20.5 minutes) than in the EPLBD with EST group (18 minutes; P = 0.08).
Conclusion The therapeutic outcomes and adverse events of EPLBD alone for the removal of large bile duct stones were comparable to those of EPLBD with EST.
* These authors contributed equally.
-
References
- 1 Ersoz G, Tekesin O, Ozutemiz AO. et al. Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract. Gastrointest Endosc 2003; 57: 156-159
- 2 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
- 3 Itoi T, Itokawa F, Sofuni A. et al. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol 2009; 104: 560-565
- 4 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy 2007; 39: 958-961
- 5 Misra S, Dwivedi M. Large-diameter balloon dilation after endoscopic sphincterotomy for removal of difficult bile duct stones. Endoscopy 2008; 40: 209-213
- 6 Oh MJ, Kim TN. Prospective comparative study of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for removal of large bile duct stones in patients above 45 years of age. Scand J Gastroenterol 2012; 47: 1071-1077
- 7 Kim TH, Oh HJ, Lee JY. et al. Can a small endoscopic sphincterotomy plus a large-balloon dilation reduce the use of mechanical lithotripsy in patients with large bile duct stones?. Surg Endosc 2011; 25: 3330-3337
- 8 Heo JH, Kang DH, Jung HJ. et al. Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones. Gastrointest Endosc 2007; 66: 720-726
- 9 Chan H, Lai K, Lin C. et al. Endoscopic papillary large balloon dilation alone without sphincterotomy for the treatment of large common bile duct stones. BMC Gastroenterology 2011; 11: 69
- 10 Jeong S, Ki S, Lee DH. et al. Endoscopic large-balloon sphincteroplasty without preceding sphincterotomy for the removal of large bile duct stones: a preliminary study. Gastrointest Endosc 2009; 70: 915-922
- 11 Hwang JC, Kim JH, Lim SG. et al. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol 2013; 13: 15
- 12 Kogure H, Tsujino T, Isayama H. et al. Short-and long-term outcomes of endoscopic papillary large balloon dilation with or without sphincterotomy for removal of large bile duct stones. Scand J Gastroenterol 2013; 49: 121-128
- 13 Li QL, Gao WD, Zhang C. et al. Is endoscopic sphincterotomy plus large-balloon dilation a better option than endoscopic large-balloon dilation alone in removal of large bile duct stones? A retrospective comparison study. Indian J Cancer 2015; 51: e13-17
- 14 Baron TH, Harewood GC. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a meta-analysis of randomized, controlled trials. Am J Gastroenterol 2004; 99: 1455-1460
- 15 Mac Mathuna P, Siegenberg D, Gibbons D. et al. The acute and long-term effect of balloon sphincteroplasty on papillary structure in pigs. Gastrointest Endosc 1996; 44: 650-655
- 16 Ohashi A, Tamada K, Tomiyama T. et al. Epinephrine irrigation for the prevention of pancreatic damage after endoscopic balloon sphincteroplasty. J Gastroenterol Hepatol 2001; 16: 568-571
- 17 Akashi R, Kiyozumi T, Tanaka T. et al. Mechanism of pancreatitis caused by ERCP. Gastrointest Endosc 2002; 55: 50-54
- 18 Attasaranya S, Cheon YK, Vittal H. et al. Large-diameter biliary orifice balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series. Gastrointest Endosc 2008; 67: 1046-1052
- 19 Weinberg B, Shindy W, Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones. Cochrane Database Syst Rev 2006; CD004890
- 20 Vandervoort J, Soetikno RM, Tham TC. et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 2002; 56: 652-656
- 21 Fischer M, Hassan A, Sipe BW. et al. Endoscopic retrograde cholangiopancreatography and manometry findings in 1,241 idiopathic pancreatitis patients. Pancreatology 2010; 10: 444-452
- 22 Kim HS, Moon JH, Choi HJ. et al. The role of intraductal US in the management of idiopathic recurrent pancreatitis without a definite cause on ERCP. Gastrointest Endosc 2011; 73: 1148-1154
- 23 Takuma K, Kamisawa T, Hara S. et al. Etiology of recurrent acute pancreatitis, with special emphasis on pancreaticobiliary malformation. Adv Med Sci 2012; 57: 244-250
- 24 Kim DI, Kim M, Lee SK. et al. Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc 2001; 54: 42-48
- 25 Gregg JA, De Girolami P, Carr-Locke DL. Effects of sphincteroplasty and endoscopic sphincterotomy on the bacteriologic characteristics of the common bile duct. Am J Surg 1985; 149: 668-671
- 26 Bang S, Kim MH, Park JY. et al. Endoscopic papillary balloon dilation with large balloon after limited sphincterotomy for retrieval of choledocholithiasis. Yonsei Med J 2006; 47: 805-810
- 27 Youn YH, Lim HC, Jahng JH. et al. The increase in balloon size to over 15 mm does not affect the development of pancreatitis after endoscopic papillary large balloon dilatation for bile duct stone removal. Dig Dis Sci 2011; 56: 1572-1577
- 28 Park SJ, Kim JH, Hwang JC. et al. Factors predictive of adverse events following endoscopic papillary large balloon dilation: results from a multicenter series. Dig Dis Sci 2013; 58: 1100-1109