Study of Hypothermic Machine Perfusion to Improve Liver Transplant Outcomes in Adults With Hepatocellular Carcinoma Within Milan Criteria

What this Trial Is About

Researchers are evaluating the impact of using hypothermic oxygenated machine perfusion HOPE on liver grafts from brain dead donors before transplantation in patients with hepatocellular carcinoma HCC. This open-label, randomized controlled trial aims to study how HOPE may improve graft survival, reduce post-operative complications, and potentially lower cancer recurrence after liver transplantation. The study also seeks to identify biomarkers through metabolomics to predict graft outcomes and understand injury mechanisms. Participants will be randomly assigned to receive either 90 minutes of HOPE machine perfusion on the liver graft before transplantation or standard liver transplantation without machine perfusion. The trial compares these two approaches to assess differences in overall survival, graft survival, and recurrence-free survival. Blood and tissue samples will be collected to perform advanced mass spectrometry metabolomics and liquid biopsy analyses for biomarkers linked to ischemia-reperfusion injury and cancer outcomes. During the study, patients will have blood samples taken at listing and three months after transplantation to monitor changes in exosomes and miRNA expression. Follow-up will continue for up to five years to evaluate survival and recurrence rates. Researchers will also analyze correlations between metabolomic data and clinical outcomes. The total participation duration includes assessments at one, two, three, and five years post-transplant to monitor graft function and patient health.

Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation