Comparision of Endoscopic and Laparoscopic removal of Large Bile Duct Stone: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome will be a composite of complete removal of stone in the bile duct by laproscopic CBD exploration (LCE) or endoscopic method, need of more than two attempts of ERCP for bile duct clearance or occurrence of major complication.
研究概览
简要总结
Gall bladder stones are associated with common bile duct (CBD) stones in 7-12% of patients. The preferred method of removal of bile duct stone is endoscopic retrograde cholangiopancreatography (ERCP). However the success rate of bile duct stone removal decreases with increase in size of stone especially ≥ 1.5 cm stones as well as the number of procedures. On the contrary laparoscopic CBD exploration (LCE) is a single stage procedure with the advantage of having cholecystectomy in same setting, but it is associated with complications such as bile leak, conversion to open surgery and prolonged hospitalization. It is not clear which is better for large CBD stone (≥ 1.5 cm). Our aim to compare both the modalities in patients with CBD stone of size 1.5 cm or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a common bile duct stone of size 1.5 cm or more detected on a magnetic resonance cholangiopancreatography (MRCP) with or without gall stones, both pre and post cholecystectomy will be included in the study.
排除标准
- •1.Presence of acute cholecystitis 2.Presence of acute cholangitis 3.Patients with obstructive jaundice with a serum bilirubin level higher than 10 mg/dl 4.Patients with a CBD diameter less than 10 mm 5.Patients with a history of hepatobiliary surgery other than cholecystectomy 6.Patient with uncorrectable coagulopathy 7.Patient with American Society Anaeathesiology (ASA) class 3 or more 8.Patient refusal to give consent.
结局指标
主要结局
The primary outcome will be a composite of complete removal of stone in the bile duct by laproscopic CBD exploration (LCE) or endoscopic method, need of more than two attempts of ERCP for bile duct clearance or occurrence of major complication.
时间窗: at 1 month
次要结局
- 1. Complications of the intervention(2. Procedure time in minutes)