Actively Recruiting
Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation
Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2024-02-07
40
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma within Milan criteria at listing candidate for liver transplantation
- ECOG performance status 0 to 2
- Liver graft from brain dead donor
- Ability to sign informed consent
You will not qualify if you...
- Pediatric patients
- Donors after cardiac death
- Extended criteria brain dead donors requiring machine perfusion
- Living donor liver transplantation
- Split liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo liver transplantation, with some receiving graft reconditioning using D-HOPE machine perfusion for 90 minutes.
1 surgical procedure and hospitalization
Duration - Up to 1 month after surgery
Participants are monitored for graft survival and other health outcomes after liver transplantation.
Approximately 6 post-operative visits
Duration - Up to 5 years after surgery
Participants are followed to assess survival and prognostic markers related to hepatocellular carcinoma recurrence.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
AOU di Modena
Modena, MO, Italy, 41124
Actively Recruiting
Research Team
P
Paolo Magistri, MD FACS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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