Organ TransplantationLiver DysfunctionLiver Diseases
Investigational drug(s) / intervention(s)
NMP viability testing
NMP viability testing: NMP viability testing before transplantation of discarded livers
Study summary
Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the waitlist either died or were delisted for worsening of their condition.
However a substantial number of perfectly viable organs are wrongly discarded based on a highly subjective assessment as the level of acceptance varies widely depending on the physician's judgement.
The idea of using Normothermic Machine Perfusion (NMP) not only to preserve the liver graft but also for selection purposes is a concept that has been already investigated. A few trials have analyzed the value of normothermic perfusion to assess rejected liver grafts.
Several teams demonstrated that NMP provides a tool to assess organ viability pre-transplantation as the liver is able to maintain an almost physiological metabolism.
These preliminary results came from small samples, 45% of which originated from donation after circulatory death (DCD). They need confirmation in a larger sample of organs from donors with brainstem death (DBD), adapted to the French liver allocation system.
This trial will reproduce and confirm the results of the previous studies in order to establish viability testing as the de facto method for high-risk or rejected grafts. It will also validate existing viability markers so as to define a new standard for viability testing using NMP.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA :
FOR LIVER DONORS
* Donation after brainstem death (DBD)
* Liver graft refused by 5 different transplant centres and after rescue allocation ("hors tour")
FOR LIVER TRANSPLANT RECIPIENTS
* ≥ 18 years old
* Candidates for a first elective liver transplantation (patients with a pre-transplant work-up excluding: re-transplantation, emergency transplantation (e.g. fulminant hepatitis), multi-organ or heterotopic transplantation)
* UNOS status IV (non-ventilated, no vasopressor support)
* Absence of renal insufficiency defined as a GFR of less than 60 mL/min/1.73 m² for three months or more
* MELD Score ≤ 25
* Willing and able to attend follow-up examinations
* Having signed an informed consent document
NON-INCLUSION CRITERIA:
FOR LIVER DONORS
* Macroscopic features of advanced fibrosis or cirrhosis at procurement
* Transplantation using a split graft, in situ or ex situ
* Estimated cold ischemic time greater than 8 hours (5 hours maximum of graft transport in cold ischemia)
FOR LIVER TRANSPLANT RECIPIENTS
* Mentally or legally incapacitated
* Transplantation for fulminant hepatic failure
* Early or late re-transplantation
* Combined liver transplant with any other organ, en-bloc or not
* Heterotopic liver transplantation
Primary outcome measure(s)
- To assess the efficacy of NMP to provide objective assessment of the viability of livers which were initially discarded — Day 0 \- Rate of initially discarded livers eventually transplanted after viability testing using NMP
(A stopping rule will be implemented based on the incidence of initially discarded livers eventually transplanted. NMP would be considered as:
* uninteresting if the rate of discarded livers finally rescued is ≤ 25%
* and promising if ≥ 40%.)
- To assess grafts survival of rescued livers after transplantation — Month 3, among transplanted rescued livers \- Rate of functional grafts
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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