Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- early postoperative biliary fistula
研究概览
简要总结
To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.
详细描述
a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).
A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.
the study is to compare the effectiveness and safety of 2 different placement techniques:
- the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct
- a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living donor liver transplantation
- •single bile duct in the graft
排除标准
- •multiple bile ducts
研究组 & 干预措施
Transanastomotic tube
use of transanastomotic tube.
干预措施: biliary drainage tube (Device)
Transcystic tube
use of transcystic tube to drain bile duct
干预措施: biliary drainage tube (Device)
结局指标
主要结局
early postoperative biliary fistula
时间窗: 2 weeks
次要结局
- biliary stricture(2 years postoperatively)
研究者
Ahmad Mohammad Ahmad Sultan
Assistant professor
Mansoura University
