Liver Transplantation After ex Vivo Liver Perfusion

Launched by OSLO UNIVERSITY HOSPITAL · Jul 15, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to increase the number of donor livers available for transplantation, especially for patients with liver cancer. Sometimes, livers that may not work well (called "marginal livers") are discarded because it’s hard to know how well they will function after being transplanted. In this study, researchers will use a special machine to treat and test these marginal livers before surgery. The machine mimics the conditions of a transplant and allows doctors to assess the liver's health and functionality. By doing this, they hope to make more livers usable for transplantation and improve outcomes for patients who need a new liver.

To participate in this trial, individuals must be at least 18 years old and need a liver transplant due to specific conditions, such as certain types of cancer or urgent liver disease. Participants will need to sign consent forms and attend follow-up appointments. The trial is not yet recruiting, but it aims to provide important insights into how to use marginal livers effectively and could potentially change the way liver transplants are approached in the future.

Gender

ALL

Eligibility 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.