HOPE Against Cancer Recurrence in HCC

PHASE4RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Liver TransplantationHCCOncological Outcomes
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (2)

Unknown

RECRUITING

Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk, Gdansk

NOT_YET_RECRUITING

University Hospital Basel, Basel

All Listed Sponsors
lead

Philipp Dutkowski

OTHER