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NCT05951231

Liver Transplantation After ex Vivo Liver Perfusion

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-02

Completion Date

2029-02

Last Updated

2023-11-01

Healthy Volunteers

Conditions

Liver Transplant; Complications Transplant; Failure, Liver Transplant Dysfunction Transplant; Complication, Rejection Transplant Liver Metastases Liver Cancer

Interventions

PROCEDURE

Liver transplantation

Patients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria)

Inclusion Criteria: * Signed informed consent * ≥ 18 years * Indication for liver transplantation (one criteria must be met): * 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. * Cholangiocarcinoma patients who have progression or intolerance to first-line chemotherapy. * Benign liver disease with urgent need for transplantation within months, but no regular graft is available. * Life expectancy ≤ 6 months * Willing, able and expected cooperation to attend follow-up examinations * Patients who have a need for liver transplantation but cannot participate in other transplant studies or participation in another clinical trial with randomization to liver transplantation. For malignant disease the following criteria must be met: * Good performance status assessed at the discretion of the treating physician. * ECOG (Eastern Cooperative Oncology Group) 0 or 1 * Satisfactory blood tests * Hemoglobin \>8 g/dl * Neutrophiles \>1.0 (after any Granulocyte colony-stimulating factor) * Platelets \>75 * Bilirubin \<1.5 x upper normal level * ASAT (Aspartate aminotransferase), ALAT (alanine aminotransferase) \<5 x upper normal level * Albumin above lower normal level. Exclusion Criteria: * 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.