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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

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

Treatments: Procedure: Static Cold Storage; Procedure: Hypothermic Oxygented Perfusion

Study type: Observational

Funder types: Other

Identifiers

NCT06720675

HCC-HOPE_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

237 participants in 2 patient groups

SCS - Static Clod Storage

Description:

HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with SCS and a minimum follow-up of 12 months.

Treatment:

Procedure: Static Cold Storage

HOPE - Hypothermic Oxynated Perfusion

Description:

HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with HOPE and a minimum follow-up of 12 months.

Treatment:

Procedure: Hypothermic Oxygented Perfusion