Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- prevalence of residual CBD stone
研究概览
简要总结
Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.
详细描述
This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. One arm received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as control. Both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.
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 (Participant)
盲法说明
The patients are blinded to the treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with common bile duct stone
- •Complete stone removal by endoscopy as seen in occluded cholangiogram
排除标准
- •unstable vital sign
- •failed complete stone remval
- •assciated biliary malignancy or history of bile duct surgery
- •associated bile duct stricture or choledochal cyst
- •Toxic cholangitis
- •pregnancy or unable to give informed consent
结局指标
主要结局
prevalence of residual CBD stone
时间窗: 1 day
Detected residual CBD stone by endoscoic ultrasound
次要结局
- factors associated with retained CBD stone(1 day)
- Complicaion and clinical outcome(6 months)