NCT00612846终止不适用
A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 主要终点
- Bile duct clearance
研究概览
简要总结
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gallbladder stones
- •At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
- •Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)
排除标准
- •Not fit for general anaesthesia
- •Cholangitis requiring emergency ERCP
- •Previous upper GI surgery making ERCP impossible
结局指标
主要结局
Bile duct clearance
时间窗: Peri-operative
次要结局
- Morbidity and mortality(30 day or directly relating to intervention)
- Post-operative stay(Post-operative stay)
- Procedures per patient(Interventions required to acheive duct clearance)
- Conversion to open surgery(Peri-operative)
研究者
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