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HOPE to Reduce Tumour Recurrence After LT In Patients With HCC

NCT05876052 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2023-05-25

No results posted yet for this study

Summary

Hypothermic oxygenated ex-situ machine perfusion (HOPE) is a dynamic preservation method that has been developed to reduce the incidence and severity of ischaemia-reperfusion injury and to improve outcomes after liver transplantation. Whit this study Pi and collaborators hypothesize that the application of ex-situ liver perfusion before LT in HCC recipients leads to an optimization of graft function, with a decrease in ischaemia-reperfusion injury and a possible decrease in tumor cell growth. This is multicentre, prospective, two-arm, randomized, controlled, clinical trial, that will will involve patients with HCC candidate to LT. The liver grafts will be randomized in two groups to compare HOPE and static cold storage (SCS) preservation before transplantation. For each group evaluation of clinical outcomes, graft function tests, histologic findings, perfusate, tumor characteristics, and recurrence will be done.

Conditions

Interventions

DEVICE

Hypothermic oxygenated Perfusion - HOPE

HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers.

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    collaborator OTHER

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • University of Bologna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876052 on ClinicalTrials.gov