APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts

Liver Diseases Clinical Trial

— PENOFOR  

Official title:

APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04154696
• Other study ID #: P170605J
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: August 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: René ADAM, Pr
• Phone: + 33 1 45 59 30 49
• Email: rene.adam[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Procedure:
• Liver transplantation of a graft after assessment by normothermic perfusion
Liver transplantation of a graft after assessment by normothermic perfusion

Locations

Country	Name	City	State
France	AP-HP, Paul Brousse Hospital	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival = 90%	Graft survival	3 months
Secondary	Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period	Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period	36 months
Secondary	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	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
Secondary	Proportion of grafts perfused	Proportion of grafts perfused	36 months
Secondary	Proportion of grafts that were transplanted after perfusion	Proportion of grafts that were transplanted after perfusion	36 months
Secondary	Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)	Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)	15 hours
Secondary	Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)	Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)	one month
Secondary	Time interval until liver function recovery after transplantation	Time interval until liver function recovery after transplantation	one day
Secondary	One-month overall survival (without retransplantation or graft dysfunction)	One-month overall survival (without retransplantation or graft dysfunction)	one month
Secondary	One -year graft survival	One -year graft survival	one year
Secondary	Comparison of 3-months graft survival with a control group of graft considered as initially transplantable	Comparison of 3-months graft survival with a control group of graft considered as initially transplantable	3 months
Secondary	Waiting time between the two groups		36 months
Secondary	Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year	Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year	12 months