ED COMPARED TO ES FOR BILE DUCT STONE EXTRACTION

描述（摘自应用程序） EDES研究的目的是比较患者的短期结局 采用内镜球囊扩张（艾德）和内镜括约肌切开术治疗 (ES)为胆管（胆囊）结石的提取，并建立一个 数据库进行长期跟踪。 这是一个随机的，前瞻性的， 多中心、交叉研究，涉及710例受试者。 球囊扩张 失败将被交叉到括约肌切开术。 规范化随访 将在术后即刻、30天和6个月时进行。 初级 研究的终点是：比较30天发病率;比较 30天死亡率;比较严重并发症发生率;比较 艾德和ES的成功率;建立患者数据库以供将来使用 长期随访研究。 次要终点包括：比较 症状缓解率并比较手术时间。 数据分析将 组序贯分析，包括两次中期分析和最终分析。 一个 公正的委员会将审查中期业绩，并可能建议 如果发病率、死亡率和/或手术失败率过高， 发生。 目前有37名调查人员在30个机构 参与EDES的109名受试者被随机分组。 这项研究是在美国大学的种子支持下开始的。 胃肠病学，美国胃肠内窥镜学会，以及 波士顿科学公司的微创手术 这种支持足以 建立研究并开始招募受试者，但额外的资金 需要），以完成研究。

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.