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HOPE Against Cancer Recurrence in HCC
Sponsor: Philipp Dutkowski
Summary
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.
Official title: Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-08-01
Completion Date
2028-01-31
Last Updated
2025-12-16
Healthy Volunteers
No
Interventions
Hypothermic oxygenated perfusion
All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres.
Conventional cold storage
Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Locations (37)
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
University Medical Centre Hamburg-Eppendorf
Hamburg-Eppendorf, Germany
Hannover Medical School
Hanover, Germany
University of Heidelberg
Heidelberg, Germany
University of Mainz
Mainz, Germany
University of Munich Grosshadern
München, Germany
Milano Institutio Nazionale dei Tumori (Milan)
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda (Milan)
Milan, Italy
Padova University Hospital
Padova, Italy
Gemelli University Hospital
Rome, Italy
University of Udine
Udine, Italy
Lithuanian University of Health Sciences
Kaunas, Lithuania
University of Groningen and University Medical Centre Groningen
Groningen, Netherlands
University Medical Centre Rotterdam - Erasmus University Medical Center
Rotterdam, Netherlands
Oslo University Hospital
Oslo, Norway
Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
Gdansk, Poland
Medical University of Warsaw
Warsaw, Poland
Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
Lisbon, Portugal
Vall d'Hebron Barcelona Hospital Campus
Barcelona, Spain
Karolinska Institutet (Stockholm)
Stockholm, Sweden
Clarunis - University Digestive Health Care
Basel, Canton of Basel-City, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Hôpitaux universitaires de Genève
Geneva, Switzerland
University Hospitals Birmingham
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
The Royal Free Hospital (London)
London, United Kingdom
King's College Hospital (London)
London, United Kingdom
Freeman Hospital (Newcastle)
Newcastle, United Kingdom