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 Karsenti1, Emmanuel Coron2, Geoffroy Vanbiervliet3, Jocelyn Privat4, Eric Kull5, Philippe Bichard6, Bastien Perrot7, Vincent Quentin8, Arnaud Duriez9, Franck Cholet10, Clément Subtil11, Jean Christophe Duchmann12, Christine Lefort13, Hervé Hudziak14, Stéphane Koch15, Philippe Granval16, Stéphane Lecleire17, Antoine Charachon18, Karl Barange19, Elodie Metivier Cesbron20, Axel De Widerspach21, Yann Le Baleur18, Marc Barthet22, Laurent Poincloux23
  • 1Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Bercy, Charenton-le-Pont, France
  • 2Digestive Endoscopy Unit, University Hospital, Nantes, France
  • 3Digestive Endoscopy Unit, l’Archet University Hospital, Nice, France
  • 4Digestive Endoscopy Unit, Vichy Hospital, Vichy, France
  • 5Digestive Endoscopy Unit, N.D. de Mercy Hospital, Metz, France
  • 6Digestive Endoscopy Unit, Grenoble University Hospital, Grenoble, France
  • 7EA4275 – SPHERE Methods for Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France
  • 8Digestive Endoscopy Unit, St. Brieuc Hospital, St. Brieuc, France
  • 9Digestive Endoscopy Unit, Roubaix Hospital, Roubaix, France
  • 10Digestive Endoscopy Unit, University Hospital, Brest, France
  • 11Digestive Endoscopy Unit, University Hospital, Bordeaux, France
  • 12Digestive Endoscopy Unit, Compiegne Hospital, Compiegne, France
  • 13Digestive Endoscopy Unit, Jean Mermoz University Hospital, Lyon, France
  • 14Digestive Endoscopy Unit, University Hospital, Nancy, France
  • 15Digestive Endoscopy Unit, Jean Minjoz Hospital, Besançon, France
  • 16Digestive Endoscopy Unit, La Timone University Hospital, Marseille, France
  • 17Digestive Endoscopy Unit, Charles Nicolle University Hospital, Rouen, France
  • 18Digestive Endoscopy Unit, Henri Mondor University Hospital, Créteil, France
  • 19Digestive Endoscopy Unit, Purpan University Hospital, Toulouse, France
  • 20Digestive Endoscopy Unit, University Hospital, Angers, France
  • 21Digestive Endoscopy Unit, Les Nouvelles Cliniques Nantaises, Nantes, France
  • 22Digestive Endoscopy Unit, University Hospital, Marseille North, France
  • 23Digestive Endoscopy Unit, Estaing University Hospital, Clermont-Ferrand, France
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).