Ex-vivo Hypotermic Perfusion in Patients with Hepatocellular Carcinoma to Reduce the Incidence of Tumor Recurrence

Completed

• Conditions: Tumor Recurrence; Liver Carcinoma; Liver Transplant; Hepato Cellular Carcinoma (HCC); Hypothermic Oxygenated Machine Perfusion

• Registration Number: NCT06720675
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months.

Detailed Description

The gold standard treatment for Hepatocellular Carcinoma (HCC) is Liver Transplantation (LT) but, despite its success, it maintains cancer recurrence rates of 16%. Ischemia-reperfusion injury (IRI) is considered a major determinant of the higher rate of HCC recurrence associated with transplantation from ECD donors and/or organs with ischemic damage. In this field, the treatment with Machines Perfusion (MP) of the liver has gained increasing attention in the transplant community as a useful tool to relieve IRI, test the hepatic function before transplantation and potentially reconditioning the marginal organs. The current study aims to show that Hypothermic Oxygenated Perfusion (HOPE) can protect recipients not only from IRI and post-transplant complications but also from tumour recurrence, which appears to be inevitably linked to the quality of the organ. This will be done through the comparison between a retrospective group of patients with HCC who have undergone LT with graft preserved by HOPE and a retrospective group of HCC recipients who received grafts preserved without perfusion, but with Static Cold Storage (SCS) technique.

Study Timeline

• Study Start: 2022-06-03
• Primary Completion: 2024-01-08
• Study Completion: 2024-01-08
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Recipients aged 18 years or older with previous diagnosis of HCC, undergone Liver Transplantation at the Transplant Center of the IRCCS AOUBO between January 2016 and 2021
• Patients who have given informed consent to participate in the study

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of HCC tumour recurrence	From liver transplant to twelve months after LT	For the purposes of descriptive analyses, categorical variables will be expressed as frequency and percentage; continuous variables will be expressed as mean + standard deviation (SD) or with median and inter-quartile range (IQR) depending on their distributive form. Comparisons between the two groups will be made by means of Chi-Quadro tests or Fisher's test (categorical variables), t-tests or Mann-Whitney tests (means of continuous variables, depending on their type of distribution). Multiple logistic regression models will be used to identify factors associated with the appearance of tumour recurrence, in which the graft preservation method is considered as a risk factor and the main characteristics of recipient and donor are included as potential confounders. Survival analysis using Kaplan-Meier curves, log-rank test and Cox regression will be performed to assess the time between transplantation and recurrence and the factors associated with it.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy