DeFat
Research type
Research Study
Full title
Defatting of donor transplant livers during normothermic perfusion - a randomised clinical trial
IRAS ID
300545
Contact name
Peter Friend
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics & Assurance
ISRCTN Number
ISRCTN14957538
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Liver disease is the third leading cause of premature death in the UK. Liver transplantation is the only successful treatment for end-stage liver disease but is limited by a shortage of suitable donor organs.
A third of donated livers are declined for transplants due to the presence of fat within the liver cells (known as non-alcoholic fatty liver disease, NAFLD). Transplanting a fatty liver carries a greater risk to the patient compared to a normal liver as these livers do not tolerate conventional ice-box storage before transplantation.
Our preliminary experiments point to an innovative defatting strategy for treatment of fatty human livers that were declined for transplantation. These livers were preserved on a machine in very similar conditions to those in the body (termed normothermic machine perfusion; NMP). We added a combination of currently available drugs to release fat from liver cells, and we then removed the fat from the perfusion machine using a filter. This reduced the amount of fat in the liver and improved its function.
None of the livers treated in this experimental study were actually transplanted: if used for patients, we believe that this might increase the number of livers that could be transplanted safely.
In the proposed trial, we will randomly assign 60 livers from donors with a high risk of fatty liver disease to either NMP alone or NMP with fat removal treatment. We will assess how many of these livers are safe to transplant and, in those that are transplanted, follow the outcomes after the operation. The main objective is to show whether this treatment is safe; it will also help us to design a future, larger study which will test the extent to which fat removal actually leads to additional transplants.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0257
Date of REC Opinion
26 May 2022
REC opinion
Further Information Favourable Opinion