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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154696
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Diseases Procedure: Liver transplantation of a graft after assessment by normothermic perfusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Liver transplantation of a graft after assessment by normothermic perfusion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normothermic perfusion of a graft Procedure: Liver transplantation of a graft after assessment by normothermic perfusion
Liver transplantation of a graft after assessment by normothermic perfusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Proportion of grafts perfused [ Time Frame: 36 months ]
    Proportion of grafts perfused

  4. Proportion of grafts that were transplanted after perfusion [ Time Frame: 36 months ]
    Proportion of grafts that were transplanted after perfusion

  5. 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)

  6. 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)

  7. Time interval until liver function recovery after transplantation [ Time Frame: one day ]
    Time interval until liver function recovery after transplantation

  8. One-month overall survival (without retransplantation or graft dysfunction) [ Time Frame: one month ]
    One-month overall survival (without retransplantation or graft dysfunction)

  9. One -year graft survival [ Time Frame: one year ]
    One -year graft survival

  10. 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

  11. Waiting time between the two groups [ Time Frame: 36 months ]
  12. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154696


Contacts
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Contact: René ADAM, Pr + 33 1 45 59 30 49 rene.adam@aphp.fr
Contact: Marc-Antoine Allard, Dr marcantoine.allard@aphp.fr

Locations
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France
AP-HP, Paul Brousse Hospital
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04154696    
Other Study ID Numbers: P170605J
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Steatotic liver graft
Liver transplantation
Normothermic perfusion
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases