About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Donation after brainstem death (DBD)
Liver graft refused by 5 different transplant centres and after rescue allocation ("hors tour")
≥ 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)
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
NMP viability testing
Other interventionNMP viability testing before transplantation of discarded livers
Treatment groups
Trial outcomes
Primary outcomes
- To assess the efficacy of NMP to provide objective assessment of the viability of livers which were initially discarded
\- 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
\- Rate of functional grafts
Secondary outcomes
- To assess early graft dysfunction
Rate of early allograft dysfunction (EAD). EAD is defined according to Olthoff criteria by the presence of at least one of the following criteria: * bilirubin level over 171 mmol/L on PTD7, * International Normalized Ratio (INR) over 1.6 on PTD7, * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \> 2000 IU/L within the first 7 PTDs
- To assess primary non-function
Need for re-transplantation and/or death of recipient from liver failure
- To assess intraoperative morbidity
Rate of incidents during reperfusion
- To assess postoperative morbidity
Rate of adverse event and severity, graded according to the Clavien-Dindo classification
Sponsors and contacts
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