NCT06720675

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

Use of Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma Candidates for Liver Transplant to Reduce the Incidence of Tumor Recurrence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 237 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Hypothermic Oxygented Perfusion	HOPE start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid (cold Belzer MPS solution) during back-table preparation. Hepatic perfusion was performed through the vein leads to a pressure of 3-5 mmHg. Organ were treated with continuous HOPE until transplant and the perfusion was continuously monitored and data downloaded in a USB memory.
PROCEDURE	Static Cold Storage	Liver grafts are stored in sterile organ bags with cold Belzer or Celsior solution and kept in ice at 4°C.

Timeline

• Start date: 2022-06-03
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2024-12-06
• Last updated: 2025-01-30

Locations

1 site across 1 country: Italy