APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts (PENOFOR)

November 4, 2019 updated by: 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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Villejuif, France, 94800
        • AP-HP, Paul Brousse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normothermic perfusion of a graft
Liver transplantation of a graft after assessment by normothermic perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90%
Time Frame: 3 months
Graft survival
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
Time Frame: 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
Time Frame: 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
Time Frame: 36 months
Proportion of grafts perfused
36 months
Proportion of grafts that were transplanted after perfusion
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: one day
Time interval until liver function recovery after transplantation
one day
One-month overall survival (without retransplantation or graft dysfunction)
Time Frame: one month
One-month overall survival (without retransplantation or graft dysfunction)
one month
One -year graft survival
Time Frame: one year
One -year graft survival
one year
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
Time Frame: 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
Time Frame: 36 months
36 months
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
Time Frame: 12 months
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 28, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P170605J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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