Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones: A Prospective Validation Study With Postoperative MRCP Confirmation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Common bile duct clearance
研究概览
简要总结
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
详细描述
Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct
- •Eligible for laparoscopic cholecystectomy
- •Understood and signed written consent form
排除标准
- •Severe cholangitis (according to TOKYO2018 guidelines)
- •Severe pancreatitis (BISAP score of 3 or more)
- •Septic shock
- •Common bile duct stones larger than 15 mm
结局指标
主要结局
Common bile duct clearance
时间窗: 30 days
The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)
次要结局
- Operative time, 30-day post-operative complications, hospital length of stay(30 days)