Complex biliary stones management: cholangioscopy versus papillary large balloon dilation – a randomized controlled trial

Abstract

Background and study aims Endoscopic removal of biliary stones has high success rates, ranging between 85 % to 95 %. Nevertheless, some stones may be challenging and different endoscopic methods have evolved. Papillary large balloon dilation after sphincterotomy is a widely used technique with success rates ranging from 68 to 90 % for stones larger than 15 mm. Cholangioscopy allows performing lithotripsy under direct biliary visualization, either by laser or electrohydraulic waves, which have similar success rate (80 % – 90 %). However, there is no study comparing these 2 techniques.

Patients and methods From April 2014 to June 2016, 100 patients were enrolled and randomized in 2 groups, using a non-inferiority hypothesis: cholangioscopy + electrohydraulic lithotripsy (group 1) and endoscopic papillary large balloon dilation (group 2). The main outcome was complete stone removal. Adverse events were documented. Mechanical lithotripsy was not performed. Failure cases had a second session with crossover of the methods.

Results The mean age was 56 years. 74 (75.5 %) patients were female. The initial overall complete stone removal rate was 74.5 % (77.1 % in group 1 and 72 % in group 2, P > 0.05). After second session the overall success rate achieved 90.1 %. Procedure time was significantly lower in group 2, – 25.2 min (CI95 % – 12.48 to – 37.91). There were no significant differences regarding technical success rate, radiologic exposure and adverse events.

Conclusion Single-operator cholangioscopy-guided lithotripsy and papillary large balloon dilation are effective and safe approaches for removing complex biliary stones.

• References

• 1 Bergman JJ, Rauws EAJ, Tijssen JGP. et al. Biliary endoprostheses in elderly patients with endoscopically irretrievable common bile duct stones: report on 117 patients. Gastrointest Endosc 1995; 42: 195-201
• 2 Horiuchi A, Nakayama Y, Kajiyama M. et al. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc 2010; 71: 1200-1203.e2
• 3 Cotton PB. Endoscopic management of bile duct stones (apples and oranges). Gut 1984; 25: 587-597
• 4 Cairns SR, Dias L, Cotton PB. et al. Additional endoscopic procedures instead of urgent surgery for retained common bile duct stones. Gut 1989; 30: 535-540
• 5 Sivak MV. Endoscopic management of bile duct stones. Am J Surg 1989; 158: 228-240
• 6 Sherman S, Hawes RH, Lehman GA. Management of bile duct stones. Semin Liver Dis 1990; 10: 205-221
• 7 Cipoletta L, Costamagna G, Bianco MA. et al. Endoscopic mechanical lithotripsy of difficult bile duct stones. Br J Surg 1997; 84: 1407-1409
• 8 Bergman JJ, Rauws EA, Fockens P. et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones. Lancet 1997; 349: 1124-1129
• 9 Freeman ML, Nelson DB, Sherman S. et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996; 335: 909-918
• 10 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
• 11 Sharma SS, Jain P. Should we redefine large common bile duct stone?. World J Gastroenterol 2008; 14: 651-652
• 12 Heo J, Kang D, 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
• 13 Kim HJ, Choi HS, Park JH. et al. Factors influencing the technical difficulty of endoscopic clearance of bile duct stones. Gastrointest Endosc 2007; 66: 1154-1160
• 14 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
• 15 Schneider MU, Matek W, Bauer R. et al. Mechanical lithotripsy of bile duct stones in 209 patients--effect of technical advances. Endoscopy 1988; 20: 248-253
• 16 Shaw MJ, Mackie RD, Moore JP. et al. Results of a multicenter trial using a mechanical lithotripter for the treatment of large bile duct stones. Am J Gastroenterol 1993; 88: 730-733
• 17 Chang WH, Chu CH, Wang TE. et al. Outcome of simple use of mechanical lithotripsy of difficult common bile duct stones. World J Gastroenterol 2005; 11: 593-596
• 18 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy 2007; 39: 958-961
• 19 Draganov PV, Evans W, Fazel A. et al. Large size balloon dilation of the ampulla after biliary sphincterotomy can facilitate endoscopic extraction of difficult bile duct stones. J Clin Gastroenterol 2009; 43: 782-786
• 20 Stefanidis G, Viazis N, Pleskow D. et al. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol 2011; 106: 278-285
• 21 Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopan- creatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc 2007; 65: 832-841
• 22 Arya N, Nelles SE, Haber GB. et al. Electrohydraulic lithotripsy in 111 patients: a safe and effective therapy for difficult bile duct stones. Am J Gastroenterol 2004; 99: 2330-2334
• 23 Maydeo A, Kwek BE, Bhandari S. et al. Single-operator cholangioscopy-guided laser lithotripsy in patients with difficult biliary and pancreatic ductal stones (with videos). Gastrointest Endosc 2011; 74: 1308-1314
• 24 Chen YK, Parsi MA, Binmoeller KF. et al. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc 2011; 74: 805-814
• 25 Moura EG, Franzini T, Moura RN. et al. Cholangioscopy in bile duct disease: a case series. Arq Gastroenterol 2014; 51: 250-254
• 26 Trikudanathan G, Navaneethan U, Parsi MA. Endoscopic management of difficult common bile duct stones. World J Gastroenterol 2013; 19: 165-173
• 27 Yasuda I, Itoi T. Recent advances in endoscopic management of difficult bile duct stones. Dig Endosc 2013; 25: 376-385
• 28 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
• 29 Minami A, Hirose S, Nomoto T. et al. Small sphincterotomy combined with papillary dilation with large balloon permits retrieval of large stones without mechanical lithotripsy. World J Gastroenterol 2007; 13: 2179-2182
• 30 Misra SP, Dwivedi M. Large-diameter balloon dilation after endoscopic sphincterotomy for removal of difficult bile duct stones. Endoscopy 2008; 40: 209-213
• 31 Attam R, Freeman ML. Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg 2009; 16: 618-623
• 32 Lee DK, Jahng JH. Alternative methods in the endoscopic management of difficult common bile duct stones. Dig Endosc 2010; 22: S79-S84
• 33 Seelhoff A, Schumacher B, Neuhaus H. Single operator peroral cholangioscopic guided therapy of bile duct stones. J Hepatobiliary Pancreat Sci 2011; 18: 346-349
• 34 Kalaitzakis E, Webster GJ, Oppong KW. et al. Diagnostic and therapeutic utility of single-operator peroral cholangioscopy for indeterminate biliary lesions and bile duct stones. Eur J Gastroenterol Hepatol 2012; 24: 656-664
• 35 Seelhoff A, Schumacher B, Neuhaus H. Prospective study of SpyGlass guided laser lithotripsy of bile duct stones after failure of conventional endoscopic techniques. Gastrointest Endosc 2009; 69: AB261
• 36 Kurihara T, Yasuda I, Isayama H. et al. Diagnostic and therapeutic single- operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan. World J Gastroenterol 2016; 22: 1891-1901
• 37 Fukuda Y, Tsuyuguchi T, Sakai Y. et al. Diagnostic utility of peroral cholangioscopy for various bile-duct lesions. Gastrointest Endosc 2005; 62: 374-382
• 38 Farrell JJ, Bounds BC, Al-Shalabi S. et al. Single-operatorduodenoscope-assisted cholangioscopy is an effective alternative in the management of choledocholithiasis not removed by conventional methods, including mechanical lithotripsy. Endoscopy 2005; 37: 542-547