Machine oxygen flushing of donor livers before transplant in liver cancer patients

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver cancer (HCC) who are on the waiting list for a liver transplant. It compares perfused donor livers with livers kept in cold storage.

Age

Adults over 18 years

Sex

All sexes can join.

Disease stage

Liver cancer (HCC) shown on MRI or CT scan (LIRADS 5) or by biopsy. The tumour must be within the up to seven criteria: the largest tumour size in cm plus the number of tumours is at most seven. People beyond this limit can join after the tumour was successfully shrunk.

Earlier treatment

People cannot join if they had treatment with checkpoint inhibitors or multikinase inhibitors.

Main reasons for not taking part

• Liver from a donor after circulatory death (DCD)
• Combined or partial liver transplant
• Mixed liver-bile duct cancer (cHCC-CCC), pure cholangiocarcinoma or other cancers found in the removed liver
• Treatment after transplant with mTOR inhibitors
• Pregnancy

This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: Adult recipients (>18y), listed for liver transplantation with documented HCC (Liver Imaging Reporting and Data System (LIRADS) 5 lesion in magnetic resonance imaging or computer tomography of the liver or biopsy proven),

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you 18 years old or older?YesNo
• Are you on the waiting list for a liver transplant, or have you ever had an organ, bone marrow or stem cell transplant?I am on the waiting list for a liver transplantI have had a liver transplantI have had another transplant (for example kidney, heart, bone marrow or stem cells)No

What the trial wants to find out

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.

The 2 groups in the trial

• Conventional cold storageExisting treatment, for comparison

  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.

• Hypothermic oxygenated perfusionTreatment being tested

  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 (VitaSmart, Bridge to Life®, Liver Assist, XVIVO®, Perlife, Aferitica®).