APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts (PENOFOR)
2019年11月4日 更新者:Assistance Publique - Hôpitaux de Paris
APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion
This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion.
Grafts have to be allocated to one of 3 liver transplantation centres of Paris.
After evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time > 6 months.
研究概览
详细说明
In this study, the coordinator investigator proposes to build a platform for perfusing in normothermic conditions all grafts with histologically proven macrosteatosis ≥ 30% that will be considered as unsuitable for upfront LT.
These grafts have to be alloacted to one of the 3 liver transplantation centers of Assistance Publique des Hôpitaux de Paris.
Eligible grafts (macrosteatosis ≥ 30%, no severe fibrosis or cirrhosis) will be shipped to the platform for normothermic perfusion.
Perfusion will be started provided that cold ischemia time do not exceed 8 hours.
Parameters of grafts viability (lactates, bile production, flow) will be monitored.
After a minimum of 4 hours of normothermic perfusion (not exceeding 16 hours), grafts fulfilling strict criteria (homogeneous aspect of the liver without any necrotic regions, lactates < 2.5 mmol/l and continuous production of bile with at least one of the following criteria: pH of perfusate > 7.3, arterial flow > 150 ml/min and portal flow > 500 ml/min, homogeneous perfusion of the graft) will be considered suitable for transplantation.
Recipient will be transferred to the operating room, and first phase of LT (i.e, laparotomy and total hepatectomy) will be started.
Simultaneously, grafts will be shipped to the center of initial allocation.
Perfusion will be pursued during the transport from the platform to the recipient.
Recipients (≥18 years and ≤ 70 years) have to be enlisted for LT with an estimated waiting time > 6 months (i.e., MELD score < 25) and who signed an informed consent.
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Villejuif、法国、94800
- AP-HP, Paul Brousse Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients enlisted for liver transplantation for liver disease or HCC (AFP score≤ 2);
- Ongoing cotraception in women of reproductive age ;
- Patient with social security ;
- informed signed consent
Exclusion criteria:
- Extra-hepatic tumor disease;
- Re-transplantation ;
- Pregnancy or brest-feeding;
- Patients participting in another study;
- Patients under psychiatric treatment;
- Patients under tutorship or curatorship
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Normothermic perfusion of a graft
|
Liver transplantation of a graft after assessment by normothermic perfusion
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90%
大体时间:3 months
|
Graft survival
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
大体时间:36 months
|
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
|
36 months
|
|
Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion
大体时间:36 months
|
Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion
|
36 months
|
|
Proportion of grafts perfused
大体时间:36 months
|
Proportion of grafts perfused
|
36 months
|
|
Proportion of grafts that were transplanted after perfusion
大体时间:36 months
|
Proportion of grafts that were transplanted after perfusion
|
36 months
|
|
Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)
大体时间:15 hours
|
Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)
|
15 hours
|
|
Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)
大体时间:one month
|
Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)
|
one month
|
|
Time interval until liver function recovery after transplantation
大体时间:one day
|
Time interval until liver function recovery after transplantation
|
one day
|
|
One-month overall survival (without retransplantation or graft dysfunction)
大体时间:one month
|
One-month overall survival (without retransplantation or graft dysfunction)
|
one month
|
|
One -year graft survival
大体时间:one year
|
One -year graft survival
|
one year
|
|
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
大体时间:3 months
|
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
|
3 months
|
|
Waiting time between the two groups
大体时间:36 months
|
36 months
|
|
|
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
大体时间:12 months
|
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年10月28日
初级完成 (预期的)
2021年7月1日
研究完成 (预期的)
2022年4月1日
研究注册日期
首次提交
2019年8月21日
首先提交符合 QC 标准的
2019年11月4日
首次发布 (实际的)
2019年11月6日
研究记录更新
最后更新发布 (实际的)
2019年11月6日
上次提交的符合 QC 标准的更新
2019年11月4日
最后验证
2019年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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