Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion
研究概览
简要总结
The study was designed to investigate whether, compared with conventional sole perfusion with high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts with low-viscosity and high-viscosity preservation solutions could further decrease the incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.
详细描述
The exact etiology of nonanastomotic biliary strictures (NAS) with a patent hepatic artery after liver transplantation remains unclear so far. Microangiopathy is strongly suspected to be involved in the etiology, so sufficient flushing of peribiliary plexus (PBP) which directly nourishes the donor biliary tree may be pivotal to prevent NAS with a patent hepatic artery.
Solution of University of Wisconsin (UW solution) is a standard for liver graft flushing, but accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which together constitutes a hindrance to solution penetration and thorough flushing of liver microcirculation including PBP. Several studies have revealed the relationship of high viscosity of UW solution with the development of NAS.
The investigators, therefore, have hypothesized that sequential perfusion with low-viscosity and high-viscosity preservation solutions might improve the patency of PBP in contrast with conventional sole perfusion with high-viscosity UW solution, and as a result, the incidence of NAS with a patent hepatic artery after liver transplantation would be significantly decreased.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 years
- •ability to provide written informed consent prior to study entry
- •receiving a whole liver graft
- •primary transplantation
排除标准
- •participant in other clinical trials
- •fulminant liver failure as the cause of transplantation
- •primary biliary cirrhosis, autoimmune hepatitis or primary sclerosing cholangitis as primary liver disease
- •retransplantation
- •non-liver organ(s) failure prior to study entry
- •donor/recipient ABO-blood-group-incompatibility
结局指标
主要结局
Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion
时间窗: 1 week
PNF is defined as non-life-sustaining function of the graft unexplained by vascular complications or rejection, leading to death or retransplantation within postoperative 7 days.
Number of participants with nonanastomotic biliary strictures with a patent hepatic artery
时间窗: 5 years
nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation.
次要结局
- Number of participants with initial poor function (IPF)(1 week)