Hypothermic oxygenated perfusion (HOPE) against cancer recurrence in HCC liver transplantation

Background to the research: A frequent and increasing indication for liver transplantation is the presence of hepatocellular carcinoma (HCC) in a cirrhotic liver. The shortcoming, however, of including patients with HCC is tumor recurrence after liver transplantation. This occurs in approximately 15 % of cases, and is known to potentially correlate with donor liver quality. Machine liver perfusion, as for example hypothermic oxygenated liver perfusion (HOPE), is a novel method to optimize the quality of donor livers before implantation compared to the standard procedure, which is cold ice preservation.

The aim of our study is therefore to investigate, if patients with HCC have less HCC recurrence by donor liver treatment with HOPE.

The study appears timely, as HOPE is an easy and short term machine perfusion treatment of donor livers for two hours before implantation. The study is also novel, as anti-tumor effects of HOPE have not been explored in a randomized manner. If HOPE has a benefit on tumor recurrence, we expect relevant consequences for clinical practice.

Design and methods used: We plan to recruit 220 patients with liver cirrhosis and HCC listed for liver transplantation in 15 well known transplant centers. Patients will be randomized to HOPE treatment or standard cold ice preservation. We will compare time to eventual tumor recurrence or death (primary endpoint) between the two treatment groups (primary objective of this study). Secondary endpoints will include initial graft quality and liver graft injury during implantation, as well as complications after liver transplantation. The follow up period of this study will be 2 years, as most HCC recurrence after liver transplantation is kown to occur within this time frame.

Patient and public involvement: Liver transplant patients were involved in the study design and methods. They will also participate in site visits during recruitment and after completion of the study to share their experiences and the trial results with the centers and the public.