- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154696
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: René ADAM, Pr
- Phone Number: + 33 1 45 59 30 49
- Email: rene.adam@aphp.fr
Study Contact Backup
- Name: Marc-Antoine Allard, Dr
- Email: marcantoine.allard@aphp.fr
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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