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

4. november 2019 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

28. oktober 2019

Primær færdiggørelse (Forventet)

1. juli 2021

Studieafslutning (Forventet)

1. april 2022

Datoer for studieregistrering

Først indsendt

21. august 2019

Først indsendt, der opfyldte QC-kriterier

4. november 2019

Først opslået (Faktiske)

6. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P170605J

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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