ED COMPARED TO ES FOR BILE DUCT STONE EXTRACTION

描述(取自应用程序) EDES研究的目的是比较患者的短期结果 内窥镜气囊扩张术和内窥镜乳头括约肌切开术 (ES)用于胆管(胆)结石取出，并建立 用于长期跟踪的数据库。这是一个随机的，前瞻性的， 涉及710名受试者的多中心交叉研究。气囊扩张 失败将被转移到括约肌切开术。标准化随访 将在术后即刻、30天和6个月时进行。主要 研究的终点是：比较30天的发病率；比较 30天死亡率；比较严重并发症发生率；比较 急诊室和急诊室的成功率；建立患者数据库以备将来 长期随访研究。次要终端包括：要比较 比较症状缓解率和手术时间。数据分析将是 分组序贯，包括两个中期分析和一个最终分析。一个 公正的委员会将审查中期结果，并可建议 如果发病率、死亡率和/或程序失败的比率过高而终止合同 发生。目前有37名调查人员在30个机构 参加EDES的109名受试者是随机的。 这项研究是在美国大学的SEED支持下发起的 胃肠病学，美国胃肠内窥镜学会 微电子公司，波士顿科学公司。这一支持足以 建立这项研究并开始招募受试者，但需要额外的资金 是必需的)，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.