About the study
More information about why the study is needed and the potential benefits it may bring.
About the study
The DeFat study is a randomised study (2-arm, 1:1 allocation) of normothermic machine perfusion (NMP) with or without fat removal treatment in livers with a high risk of fatty liver disease. The study will recruit 60 livers (30 per arm).
Liver offers will be made to participating centres through the NHS Blood and Transplant (NHSBT) offering system (as per standard practice). Liver offers accepted by each participating transplant centre will be screened for a high likelihood of fatty liver disease at each point of the donor pathway. In addition, any liver offers fast-tracked due to moderate-severe steatosis (fatty liver disease) will also be considered for enrolment.
On arrival at the transplant hospital, a surgeon from the implanting team will assess the liver to confirm its suitability for inclusion into the trial (based on appearance or clinical biopsy result). The objective of this second entry criterion is to reduce the number of false positive (non-fatty) livers enrolled in the trial.
Participants will be followed up for 6 months after their transplant. One-year post-transplant follow-up data will be obtained from the NHSBT registry.
The primary objective of the study is to confirm the safety and assess efficacy of the NMP-defatting protocol in steatotic livers intended for transplant. The secondary objectives include clinical, histological, biochemical and imaging objectives.
Patients and their families have contributed to the design of the study and will be members of the committee that run it. They believe the study is addressing an important issue, particularly in the context of the global obesity crisis and its consequent implications for liver transplantation.
For more information about the study please contact our team at DeFat@nhsbt.nhs.uk.