Using machine perfusion to improve liver transplant outcomes for patients with liver cancer
Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation
This study tests whether a special cooling method for liver grafts can help improve transplant success and reduce complications for patients with liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 1 site (Modena, MO) |
| Trial ID | NCT06236568 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of hypothermic machine perfusion on liver grafts prior to transplantation in patients with hepatocellular carcinoma (HCC). The approach aims to enhance graft survival and reduce complications by mitigating ischemia-reperfusion injury through advanced perfusion techniques. By identifying biomarkers that predict graft outcomes, the study seeks to provide a non-invasive method for assessing graft health before transplantation. The research focuses on patients who meet specific criteria for liver transplantation and utilizes mass spectrometry-based metabolomics for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with hepatocellular carcinoma who meet the Milan criteria and are listed for liver transplantation.
Not a fit: Patients who are pediatric, have DCD donors, or are undergoing living donor liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved transplant outcomes and reduced recurrence of liver cancer in patients undergoing liver transplantation.
How similar studies have performed: Other studies have shown promising results with machine perfusion techniques, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with HCC within Milan criteria at listing candidate for liver transplantation * ECOG 0-2 * DBD donors * capability to sign an informed consent Exclusion Criteria: * pediatric patients * DCD donors * DBD extended criteria requiring machine perfusion (no ethical randomization) * living donor liver transplantation * split liver
Where this trial is running
Modena, MO
- AOU di Modena — Modena, Mo, Italy (Recruiting)
Study contacts
- Principal investigator: Eduardo M Sommella — University of Salerno
- Study coordinator: Paolo Magistri, MD FACS
- Email: paolo.magistri@unimore.it
- Phone: +390594225265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.