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

Autor:	Karsenti D; Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Bercy, Charenton-le-Pont, France., Coron E; Digestive Endoscopy Unit, University Hospital, Nantes, France., Vanbiervliet G; Digestive Endoscopy Unit, l'Archet University Hospital, Nice, France., Privat J; Digestive Endoscopy Unit, Vichy Hospital, Vichy, France., Kull E; Digestive Endoscopy Unit, N.D. de Mercy Hospital, Metz, France., Bichard P; Digestive Endoscopy Unit, Grenoble University Hospital, Grenoble, France., Perrot B; EA4275 - SPHERE Methods for Patient-centered outcomes and HEalth ResEarch, Nantes University, Nantes, France., Quentin V; Digestive Endoscopy Unit, St. Brieuc Hospital, St. Brieuc, France., Duriez A; Digestive Endoscopy Unit, Roubaix Hospital, Roubaix, France., Cholet F; Digestive Endoscopy Unit, University Hospital, Brest, France., Subtil C; Digestive Endoscopy Unit, University Hospital, Bordeaux, France., Duchmann JC; Digestive Endoscopy Unit, Compiegne Hospital, Compiegne, France., Lefort C; Digestive Endoscopy Unit, Jean Mermoz University Hospital, Lyon, France., Hudziak H; Digestive Endoscopy Unit, University Hospital, Nancy, France., Koch S; Digestive Endoscopy Unit, Jean Minjoz Hospital, Besançon, France., Granval P; Digestive Endoscopy Unit, La Timone University Hospital, Marseille, France., Lecleire S; Digestive Endoscopy Unit, Charles Nicolle University Hospital, Rouen, France., Charachon A; Digestive Endoscopy Unit, Henri Mondor University Hospital, Créteil, France., Barange K; Digestive Endoscopy Unit, Purpan University Hospital, Toulouse, France., Cesbron EM; Digestive Endoscopy Unit, University Hospital, Angers, France., De Widerspach A; Digestive Endoscopy Unit, Les Nouvelles Cliniques Nantaises, Nantes, France., Le Baleur Y; Digestive Endoscopy Unit, Henri Mondor University Hospital, Créteil, France., Barthet M; Digestive Endoscopy Unit, University Hospital, Marseille North, France., Poincloux L; Digestive Endoscopy Unit, Estaing University Hospital, Clermont-Ferrand, France.
Jazyk:	angličtina
Zdroj:	Endoscopy [Endoscopy] 2017 Oct; Vol. 49 (10), pp. 968-976. Date of Electronic Publication: 2017 Jul 28.
DOI:	10.1055/s-0043-114411
Abstrakt:	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). Competing Interests: Competing interests: None (© Georg Thieme Verlag KG Stuttgart · New York.)
Databáze:	MEDLINE
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