Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- all morbidity related to bile duct
研究概览
简要总结
The purpose of this study was to compare the incidence and severity of biliary complications due to liver transplantation after choledochocholedochostomy with or without a T-tube. A per-protocol analysis was designed for recipients of orthotopic liver transplantation in a single center, who were randomly assigned to choledochocholedochostomy with or without a T-tube. It is a prospective and randomized study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of a deceased full-size liver graft
- •Aged > 18 years
排除标准
- •Age < 18 years
- •Retransplantation
- •Primary sclerosing cholangitis
- •Fulminant hepatic failure
- •Technical need for a hepaticojejunostomy
- •Splitted graft
- •Reduced-size graft
- •More than one organ transplantation
- •Living donation
- •Finding of a large difference (twice the size) in common bile duct diameters between the graft and the recipient
研究组 & 干预措施
Bile duct anastomosis with T-tube
干预措施: Choledocho-choledochostomy with T-tube (Device)
Bile duct anastomosis without T-tube
干预措施: Choledocho-choledochostomy without T-tube (Device)
结局指标
主要结局
all morbidity related to bile duct
时间窗: The first year after liver transplantation procedure
All the complications related to bile duct that appear after transplantation will be recorded in both groups. All patients will be followed up for the first 12 months after transplantation.
次要结局
未报告次要终点
研究者
Rafael Lopez Andujar
Head of Unit
Hospital Universitario La Fe