ED COMPARED TO ES FOR BILE DUCT STONE EXTRACTION

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DESCRIPTION (Taken from application) The aim of the EDES Study is to compare the short term outcomes of patients treated with endoscopic balloon dilation (ED) and endoscopic sphincterotomy (ES) for bile duct (gallbladder) stone extraction, and to establish a database for long term follow-up. This is a randomized, prospective, multicenter, cross-over study to involve 710 subjects. Balloon dilation failures will be crossed-over to sphincterotomy. Standardized follow-up will be immediately post-procedure, at 30 days and at 6 months. Primary endpoints of the study are: to compare 30 day morbidity rates; to compare 30 day mortality rates; to compare severe complication rates; to compare success rates of ED and ES; to establish a database of patients for future long-term follow-up studies. Secondary endpoints include: to compare symptom relief rates and to compare procedure times. Data analysis will be group sequential with two interim analyses and a final analysis. An impartial committee will review the interim results and may recommend termination if undue rates of morbidity, mortality and/or procedural failure occurs. There are currently 37 investigators at 30 institutions participating in EDES and 109 subjects are randomized. This study was initiated with seed support from the American College of Gastroenterology, the American Society for Gastrointestinal Endoscopy, and Microvasive, Boston Scientific Corporation. This support was sufficient to establish the study and begin enrolling subjects, however additional funding is required) to complete the study.