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 (eFirst)

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).