Liver Transplantation After ex Vivo Liver Perfusion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorOslo University Hospital

About this trial

Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- \& reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.

Eligibility criteria

Qualifiers

Signed informed consent

≥ 18 years

Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study.

Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment.

Disqualifiers

Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame.

Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study.

Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial.

Any reason why, in the opinion of the investigator, the patient should not participate.

Trial design

Treatments tested in this trial

  • Liver transplantation

Treatment groups

22 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator