HCC Hepatocellular carcinoma Liver cancer
Conditions
Interventions
All participating centers will use VitaSmart®, Liver Assist® or Perlife® 
devices for machine liver perfusion. These devices are used for controlled 
hypothermic oxygenated liver perfusion via the portal vein (HOPE) or via both 
the portal vein and hepatic artery (DHOPE), with a target flow rate of 150-250 
ml/min at a pressure of 3-5 mmHg and a perfusion fluid temperature of 8-12°C. 
The perfusion fluid consists of 3L recirculating Belzer MPS® (Bridge to Life 
Ltd.) with active oxygenation (70-110 kPa). The minimum duration of perfusion 
is set at 2 hours, and perfusion is generally continued until recipient 
hepatectomy is completed. The perfusion devices are certified for human use and 
operated by trained transplant surgeons.
Sponsors
Clarunis - University Digestive Health Care Centre Basel
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Adult recipients (>18y), listed for liver transplantation with documented HCC (LIRADS-5 lesion in MRI or CT ofthe liver or biopsy proven), - within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and thenumber of tumours at the timepoint of liver transplantation, - written informed consent for the trial. This includes also patients beyond the up to seven criteria after successfuldownsizing of the HC
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Exclusion criteria: - Donation after circulatory death (DCD) liver grafts - Combined liver transplants - Partial liver transplants - Combined or mixed hepatocellular cholangiocarcinoma (cHCCCCC) or pure cholangiocarinoma or othermalignancies in histopathology of the liver explant - Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors - Post transplant treatment with mTOR inhibitors - Acute and unexpected medical contraindication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of this study is survival without HCC recurrence after liver transplantation. This is defined as the period during which a patient remains alive without experiencing HCC recurrence, until the moment when either a recurrence is observed, or the patient dies from another cause. The outcome will be evaluated using a time-to-event analysis, comparing the hazard ratio (HR) between the intervention (HOPE/DHOPE) and the control (cold storage). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include: postoperative morbidity (complications within 30 days after transplantation), inflammatory responses (CRP, IL-6, and HMGB1 levels), functional liver parameters (ALT, AST, INR, bilirubin, alkaline phosphatase), immune responses, graft-related complications, length of hospital stay, and overall survival. These parameters will be assessed through a combination of clinical data, laboratory tests, and imaging techniques. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Lithuania, Netherlands, Norway, Poland, Sweden, Switzerland, United Kingdom
Contacts
Public ContactPD Dutkowski
Clarunis - University Digestive Health Care Centre Basel
Outcome results
None listed