跳至主要内容
临床试验/NCT01907750
NCT01907750Unknown3 期

Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.

Mansoura University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
180
试验地点
2
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:

  1. 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
  2. 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

入选标准

  • living donor liver transplantation
  • single bile duct in the graft

排除标准

  • multiple bile ducts

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Mohammad Ahmad Sultan

Assistant professor

Mansoura University

研究点 (2)

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