Endoscopy 2017; 49(10): 968-976
DOI: 10.1055/s-0043-114411
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study

David Karsenti
1   Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Bercy, Charenton-le-Pont, France
,
Emmanuel Coron
2   Digestive Endoscopy Unit, University Hospital, Nantes, France
,
Geoffroy Vanbiervliet
3   Digestive Endoscopy Unit, l’Archet University Hospital, Nice, France
,
Jocelyn Privat
4   Digestive Endoscopy Unit, Vichy Hospital, Vichy, France
,
Eric Kull
5   Digestive Endoscopy Unit, N.D. de Mercy Hospital, Metz, France
,
Philippe Bichard
6   Digestive Endoscopy Unit, Grenoble University Hospital, Grenoble, France
,
Bastien Perrot
7   EA4275 – SPHERE Methods for Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France
,
Vincent Quentin
8   Digestive Endoscopy Unit, St. Brieuc Hospital, St. Brieuc, France
,
Arnaud Duriez
9   Digestive Endoscopy Unit, Roubaix Hospital, Roubaix, France
,
Franck Cholet
10   Digestive Endoscopy Unit, University Hospital, Brest, France
,
Clément Subtil
11   Digestive Endoscopy Unit, University Hospital, Bordeaux, France
,
Jean Christophe Duchmann
12   Digestive Endoscopy Unit, Compiegne Hospital, Compiegne, France
,
Christine Lefort
13   Digestive Endoscopy Unit, Jean Mermoz University Hospital, Lyon, France
,
Hervé Hudziak
14   Digestive Endoscopy Unit, University Hospital, Nancy, France
,
Stéphane Koch
15   Digestive Endoscopy Unit, Jean Minjoz Hospital, Besançon, France
,
Philippe Granval
16   Digestive Endoscopy Unit, La Timone University Hospital, Marseille, France
,
Stéphane Lecleire
17   Digestive Endoscopy Unit, Charles Nicolle University Hospital, Rouen, France
,
Antoine Charachon
18   Digestive Endoscopy Unit, Henri Mondor University Hospital, Créteil, France
,
Karl Barange
19   Digestive Endoscopy Unit, Purpan University Hospital, Toulouse, France
,
Elodie Metivier Cesbron
20   Digestive Endoscopy Unit, University Hospital, Angers, France
,
Axel De Widerspach
21   Digestive Endoscopy Unit, Les Nouvelles Cliniques Nantaises, Nantes, France
,
Yann Le Baleur
18   Digestive Endoscopy Unit, Henri Mondor University Hospital, Créteil, France
,
Marc Barthet
22   Digestive Endoscopy Unit, University Hospital, Marseille North, France
,
Laurent Poincloux
23   Digestive Endoscopy Unit, Estaing University Hospital, Clermont-Ferrand, France
› Author Affiliations
Further Information

Publication History

submitted 03 February 2017

accepted after revision: 14 May 2017

Publication Date:
28 July 2017 (online)

Abstract

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones.

Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed.

Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones.

Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.

Trial registered at ClinicalTrials.gov (NCT02592811).

 
  • References

  • 1 Kawai K, Akasaka Y, Murakami K. et al. Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 1974; 20: 148-151
  • 2 Gupta N, Poreddy V, Al-Kawas F. Endoscopy in the management of choledocholithiasis. Curr Gastroenterol Rep 2008; 10: 169-176
  • 3 McHenry L, Lehman G. Difficult bile duct stones. Curr Treat Options Gastroenterol 2006; 9: 123-132
  • 4 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
  • 5 Karsenti D. Endoscopic management of bile duct stones: residual bile duct stones after surgery, cholangitis, and “difficult stones”. J Visc Surg 2013; 150: S39-46
  • 6 Rouquette O, Bommelaer G, Abergel A. et al. Large balloon dilation post endoscopic sphincterotomy in removal of difficult common bile duct stones: a literature review. World J Gastroenterol 2014; 20: 7760-7766
  • 7 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
  • 8 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
  • 9 Rosa B, Moutinho Ribeiro P, Rebelo A. et al. Endoscopic papillary balloon dilation after sphincterotomy for difficult choledocholithiasis: a case-controlled study. World J Gastrointest Endosc 2013; 5: 211-218
  • 10 Park JS, Kim TN, Kim KH. Endoscopic papillary large balloon dilation for treatment of large bile duct stones does not increase the risk of post-procedure pancreatitis. Dig Dis Sci 2014; 59: 3092-3098
  • 11 Li G, Pang Q, Zhang X. et al. Dilation-assisted stone extraction: an alternative method for removal of common bile duct stones. Dig Dis Sci 2014; 59: 857-864
  • 12 Kim HG, Cheon YK, Cho YD. et al. Small sphincterotomy combined with endoscopic papillary large balloon dilation versus sphincterotomy. World J Gastroenterol 2009; 15: 4298-4304
  • 13 Jun Bo Q, Li Hua X, Tian Min C. et al. Small endoscopic sphincterotomy plus large-balloon dilation for removal of large common bile duct stones during ERCP. Pak J Med Sci 2013; 29: 907-912
  • 14 Teoh AYB, Cheung FKY, Hu B. et al. Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones. Gastroenterology 2013; 144: 341-345.e1
  • 15 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
  • 16 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
  • 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
  • 18 Feng Y, Zhu H, Chen X. et al. Comparison of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for retrieval of choledocholithiasis: a meta-analysis of randomized controlled trials. J Gastroenterol 2012; 47: 655-663
  • 19 Yang X-M, Hu B. Endoscopic sphincterotomy plus large-balloon dilation vs endoscopic sphincterotomy for choledocholithiasis: a meta-analysis. World J Gastroenterol 2013; 19: 9453-9460
  • 20 Jin P-P, Cheng J-F, Liu D. et al. Endoscopic papillary large balloon dilation vs endoscopic sphincterotomy for retrieval of common bile duct stones: a meta-analysis. World J Gastroenterol 2014; 20: 5548-5556
  • 21 Xu L, Kyaw MH, Tse YK. et al. Endoscopic sphincterotomy with large balloon dilation versus endoscopic sphincterotomy for bile duct stones: a systematic review and meta-analysis. BioMed Res Int 2015; 2015: 673103
  • 22 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
  • 23 Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy 2007; 39: 958-961
  • 24 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
  • 25 Paspatis GA, Konstantinidis K, Tribonias G. et al. Sixty- versus thirty-seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: a randomized controlled trial. Dig Liver Dis 2013; 45: 301-304
  • 26 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
  • 27 Kim HW, Kang DH, Choi CW. et al. Limited endoscopic sphincterotomy plus large balloon dilation for choledocholithiasis with periampullary diverticula. World J Gastroenterol 2010; 16: 4335-4340