APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts

NCT ID: NCT04154696

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2022-04-01

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.

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.

Conditions

Liver Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normothermic perfusion of a graft

Group Type: EXPERIMENTAL

Liver transplantation of a graft after assessment by normothermic perfusion

Intervention Type: PROCEDURE

Liver transplantation of a graft after assessment by normothermic perfusion

Interventions

Liver transplantation of a graft after assessment by normothermic perfusion

Liver transplantation of a graft after assessment by normothermic perfusion

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AP-HP, Paul Brousse Hospital

Villejuif, , France

Countries

France

Central Contacts

René ADAM, Pr

Role: CONTACT

rene.adam@aphp.fr

+ 33 1 45 59 30 49

Marc-Antoine Allard, Dr

Role: CONTACT

marcantoine.allard@aphp.fr

Other Identifiers

P170605J

Identifier Type: -

Identifier Source: org_study_id