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Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received. Machine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion. The objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recurrence is improved when the liver is perfused before implantation. The study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rutgers New Jersey Medical School (New York)
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
University Hospitals Leuven
Leuven, Belgium
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Woluwe-Saint-Lambert, Belgium
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Prague, Czechia
Copenhagen University Hospital
Copenhagen, Denmark
Hôpital de la Croix-Rousse (Lyon)
Lyon, France
Universitätsklinikum Essen
Essen, Germany
Start Date
August 1, 2025
Primary Completion Date
January 31, 2028
Completion Date
January 31, 2028
Last Updated
December 16, 2025
220
ESTIMATED participants
Hypothermic oxygenated perfusion
PROCEDURE
Conventional cold storage
PROCEDURE
Lead Sponsor
Philipp Dutkowski
NCT07291076
NCT05581004
Data Source & Attribution
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