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临床试验/NCT01189734
NCT01189734已完成不适用

Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones

Mansoura University1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2010年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
1
主要终点
success/failure of common bile duct removal

研究概览

简要总结

Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
12 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •preoperatively diagnosed common bile duct stones

排除标准

  • •liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy

研究组 & 干预措施

laparoscopic common bile duct exploration

Placebo Comparator

干预措施: laparoscopic common bile duct exploration (Procedure)

laparoscopic cholecystectomy with intraoperative ES

Active Comparator

干预措施: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy (Procedure)

结局指标

主要结局

success/failure of common bile duct removal

次要结局

  • Surgical time

研究者

申办方类型
Other

研究点 (1)

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