A Prospective Randomized Controlled Trial for Application of External Biliary Drainage in Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of biliary complication within 1 year after LDLT
研究概览
简要总结
This study was designed to demonstrate incidence of biliary complication rates after living donor liver transplantation according to the implantation of external biliary drainage throug duct-to-duct anastomosis site.
详细描述
Biliary complication is the most common complications after liver transplantation, and it happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation.
Many transplant centers adopted their own methods to improve biliary complications after LDLT. One suggested method is the application of external biliary drainage (EBD).
A prospective study was planned to demonstrate effect of EBD on biliary complication after LDLT. Patients who underwent LDLT with duct-to-duct anastomosis will be randomly assinged to application of EBD or conventional duct-to-duct anastomosis without EBD according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two groups.
Primary outcome is biliary complication incidence 1 year after LDLT.
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
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living donor liver transplantation
- •Adult patient (>=18 years old)
- •Patients who are available for at least 3 year follow-up after LDLT
排除标准
- •Patients requring hepaticojejunostomy due to anatomical factor or underlying disease
- •Re-transplantation
- •Multiorgan transplantation
- •Emergency transplantation
研究组 & 干预措施
Experimental group
Application of external biliary drainage
干预措施: External biliary drainage (Procedure)
Control group
Conventional duct-to-duct anastomosis (with or without internal stent)
结局指标
主要结局
Incidence of biliary complication within 1 year after LDLT
时间窗: 1 year
Biliary stricture/leakage
次要结局
- Patient survival(3 year)
- Graft survival(3 year)
- Complication associated with external biliary drainage(3 year)
- Patient-reported outcome(3 year)
- Incidence of biliary complication within 3 year after LDLT(3 year)
研究者
Suk Kyun Hong
Clinical Assistant Professor
Seoul National University Hospital