Safe Transplantation of Extended Criteria Donor Livers: Two-center Experience With Resuscitation and Viability Assessment of 206 Livers Using Sequential Hypo- and Normothermic Machine Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Death-censored graft survival
研究概览
简要总结
The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are:
- Death censored graft-survival
- Overall patient survival
- Frequency of frequent post-transplant complications (e.g. non-anastomotic biliary strictures)
详细描述
With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old)
- •Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.
排除标准
- •Multiorgan transplantation
- •Split liver transplant
- •Living donor liver transplantation
- •Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)
研究组 & 干预措施
Group 1
Adult patients (>18 years) who underwent liver transplantation of donor livers that required resuscitation and viability assessment through the previously published protocol for sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate.
干预措施: DHOPE-COR-NMP (Procedure)
结局指标
主要结局
Death-censored graft survival
时间窗: 1 year post-transplant
Time from liver transplantation until re-transplantation or death due to graft dysfunction, with censoring of subjects who died with a functioning graft.
次要结局
- Overall patient survival(1 year post-transplant)
- • Overall graft survival(1 year post-transplant)
- Number of participants with primary non function(From transplantation until 7 days post-transplant)
- Occurrence of hepatic arterial thrombosis(1 year post-transplant)
- Occurrence of portal vein thrombosis(1 year post-transplant)
- Occurrence of venous outflow tract obstruction(1 year post-transplant)
- Occurrence of non-anastomotic biliary strictures(1 year post-transplant)
- Occurrence of anastomotic biliary strictures(1 year post-transplant)
- Occurrence of biliary leakage(From 3 days after transplantation until the the first year post-transplant)
- Biliary complications: as a composite(1 year post-transplant)
- Intensive care stay(From transplantation until discharge from the Intensive care unit to the ward after transplantation or date of death from any cause during initial admission, whichever came first, assessed up to 6 months)
- Total hospital stay(From transplantation until discharge after transplantation, or date of death from any cause during initial admission, whichever came first, assessed up to 6 months)
研究者
Prof. Robert J. Porte
Head of HPB- and Transplant Surgery
Erasmus Medical Center