Clin Endosc.  2015 Jan;48(1):59-65. 10.5946/ce.2015.48.1.59.

Twenty-Second versus Sixty-Second Dilation Duration in Endoscopic Papillary Balloon Dilation for the Treatment of Small Common Bile Duct Stones: A Prospective Randomized Controlled Multicenter Trial

• Bang BW
• Lee TH
• Song TJ
• Han JH
• Choi HJ
• Moon JH
• Kwon CI
• Jeong S

• KMID: 2221760
• DOI: http://doi.org/10.5946/ce.2015.48.1.59

Abstract

BACKGROUND/AIMS
Endoscopic papillary balloon dilation (EPBD) has been advocated as an alternative therapy to endoscopic sphincterotomy for the treatment of common bile duct (CBD) stones. However, there is no established consensus on the optimal balloon dilation duration (BDD). We prospectively evaluated the efficacy and post-endoscopic retrograde cholangiopancreatography (ERCP) complications between the 20- and 60-second EPBD groups.
METHODS
A total of 228 patients with small CBD stones (< or =12 mm) were randomly assigned to undergo EPBD with a 20- or 60-second duration at six institutions. We evaluated baseline patient characteristics, endoscopic data, clinical outcomes, and procedure-related complications. In addition, we analyzed risk factors for postprocedural pancreatitis.
RESULTS
CBD stones were removed successfully in 107 of 109 patients (98.1%) in the 20-second group and in 112 of 119 patients (94.1%) in the 60-second group (p=0.146). Post-ERCP pancreatitis developed in seven patients (6.4%) in the 20-second group and nine patients (7.5%) in the 60-second group (p=0.408). In multivariate analysis, contrast dye injection into the pancreatic duct is a significant risk factor for post-EPBD pancreatitis.
CONCLUSIONS
Based on the data showing that there were no significant differences in safety and efficacy between the two BDD groups, 20 seconds of BDD may be adequate for treatment of small CBD stones with EPBD.

Keyword

Cholangiopancreatography; Endoscopic retrograde; Choledocholithiasis; Pancreatitis

MeSH Terms

Choledocholithiasis
Common Bile Duct*
Consensus
Humans
Multivariate Analysis
Pancreatic Ducts
Pancreatitis
Prospective Studies*
Risk Factors
Sphincterotomy, Endoscopic

Reference

1. Staritz M, Ewe K, Meyer zum Büschenfelde KH. Endoscopic papillary dilation (EPD) for the treatment of common bile duct stones and papillary stenosis. Endoscopy. 1983; 15(Suppl 1):197–198. PMID: 6872989.

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. PMID: 8536511.

3. Sato H, Kodama T, Takaaki J, et al. Endoscopic papillary balloon dilatation may preserve sphincter of Oddi function after common bile duct stone management: evaluation from the viewpoint of endoscopic manometry. Gut. 1997; 41:541–544. PMID: 9391256.

4. Park DH, Kim MH, 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. PMID: 15278041.

5. Campo Fernández del os Ríos R, Brullet Benedí E. Endoscopic treatment of choledocholithiasis in patients with Billroth II gastrectomy by dilatation with papillary balloon. Gastroenterol Hepatol. 1998; 21:391–393. PMID: 9844277.

6. Liao WC, Huang SP, Wu MS, Lin JT, Wang HP. Comparison of endoscopic papillary balloon dilatation and sphincterotomy for lithotripsy in difficult sphincterotomy. J Clin Gastroenterol. 2008; 42:295–299. PMID: 18223494.

7. Lin CK, Lai KH, Chan HH, et al. Endoscopic balloon dilatation is a safe method in the management of common bile duct stones. Dig Liver Dis. 2004; 36:68–72. PMID: 14971818.

8. Tanaka S, Sawayama T, Yoshioka T. Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: long-term outcomes in a prospective randomized controlled trial. Gastrointest Endosc. 2004; 59:614–618. PMID: 15114302.

9. Natsui M, Narisawa R, Motoyama H, et al. What is an appropriate indication for endoscopic papillary balloon dilation? Eur J Gastroenterol Hepatol. 2002; 14:635–640. PMID: 12072597.

10. 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. PMID: 9113010.

11. 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 metaanalysis of randomized, controlled trials. Am J Gastroenterol. 2004; 99:1455–1460. PMID: 15307859.

12. 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. PMID: 15520997.

13. Liu Y, Su P, Lin S, et al. Endoscopic papillary balloon dilatation versus endoscopic sphincterotomy in the treatment for choledocholithiasis: a meta-analysis. J Gastroenterol Hepatol. 2012; 27:464–471. PMID: 21913984.

14. 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. PMID: 18086110.

15. Bang BW, Jeong S, Lee DH, et al. The ballooning time in endoscopic papillary balloon dilation for the treatment of bile duct stones. Korean J Intern Med. 2010; 25:239–245. PMID: 20830219.

16. 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. PMID: 20869710.

17. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991; 37:383–393. PMID: 2070995.

18. Lee TH, Moon JH, Choi HJ, et al. Prophylactic temporary 3F pancreatic duct stent to prevent post-ERCP pancreatitis in patients with a difficult biliary cannulation: a multicenter, prospective, randomized study. Gastrointest Endosc. 2012; 76:578–585. PMID: 22771100.

19. 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. PMID: 15654778.

20. Attam R, Freeman ML. Endoscopic papillary balloon dilation for stone extraction: if, when, and for how long? Gastrointest Endosc. 2010; 72:1163–1166. PMID: 21111869.

21. Li NP, Liu JQ, Zhou ZQ, Ji TY, Cai XY, Zhu QY. Ampulla dilation with different sized balloons to remove common bile duct stones. World J Gastroenterol. 2013; 19:903–908. PMID: 23431070.

22. 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. PMID: 22642953.

23. Toda N, Saito K, Wada R, et al. Endoscopic sphincterotomy and papillary balloon dilation for bile duct stones. Hepatogastroenterology. 2005; 52:700–704. PMID: 15966186.

24. 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. PMID: 17234559.

25. Ersoz G, Tekesin O, Ozutemiz AO, Gunsar F. Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract. Gastrointest Endosc. 2003; 57:156–159. PMID: 12556775.

26. Jeong S, Ki SH, 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. PMID: 19647241.

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. PMID: 20945093.

28. Meine GC, Baron TH. Endoscopic papillary large-balloon dilation combined with endoscopic biliary sphincterotomy for the removal of bile duct stones (with video). Gastrointest Endosc. 2011; 74:1119–1126. PMID: 21944309.

29. Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy. 2007; 39:958–961. PMID: 17701853.

30. Misra SP, Dwivedi M. Large-diameter balloon dilation after endoscopic sphincterotomy for removal of difficult bile duct stones. Endoscopy. 2008; 40:209–213. PMID: 18264886.

31. Chan HH, Lai KH, Lin CK, et al. Endoscopic papillary large balloon dilation alone without sphincterotomy for the treatment of large common bile duct stones. BMC Gastroenterol. 2011; 11:69. PMID: 21668994.

32. Seo YR, Moon JH, Choi HJ, et al. Papillary balloon dilation is not itself a cause of post-endoscopic retrograde cholangiopancreatography pancreatitis; results of anterograde and retrograde papillary balloon dilation. J Gastroenterol Hepatol. 2013; 28:1416–1421. PMID: 23701518.

33. Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for acute pancreatitis and hyperamylasemia after endoscopic papillary balloon dilation. Gastrointest Endosc. 2003; 57:531–535. PMID: 12665764.

34. Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996; 335:909–918. PMID: 8782497.

35. Bergman JJ, van Berkel AM, Bruno MJ, et al. Is endoscopic balloon dilation for removal of bile duct stones associated with an increased risk for pancreatitis or a higher rate of hyperamylasemia? Endoscopy. 2001; 33:416–420. PMID: 11396759.

36. Sugiyama M, Abe N, Izumisato Y, Masaki T, Mori T, Atomi Y. Risk factors for acute pancreatitis after endoscopic papillary balloon dilation. Hepatogastroenterology. 2003; 50:1796–1798. PMID: 14696407.

37. 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. PMID: 21295641.