Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Biliary complications defined as leaks and strictures within the first year post LDLT;
研究概览
简要总结
The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.
详细描述
The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.
Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with end-stage liver disease
- •living donor liver transplantation using right hemi-liver as graft
- •duct anastomosis possible at time of surgery
- •donor and recipient aged 18 yrs or older
- •written informed consent obtained
排除标准
- •duct anastomosis not possible
- •acute fulminant liver failure
结局指标
主要结局
Biliary complications defined as leaks and strictures within the first year post LDLT;
时间窗: 1 year
次要结局
- Graft and patient survival(1 year post-transplant)
- Any infection or rejection episodes(1 year post- transplant)
- time to full oral nutrition(within 30 days of discharge)
- Length of hospital-stay and ICU-stay(within first 30 days after discharge)