For patients
Information for those taking part in the DeFat study.
We would like to assess whether a new technique for removing fat from a liver can improve the safe and successful use of livers that are ordinarily offered for transplant but are retrieved from donors at risk of having a fatty liver.
The objective of this study is to make fatty livers safe for transplantation and thereby increase the number of transplants that can be safely conducted.
The need for this study
Liver transplantation is the only successful treatment for end-stage liver disease but is limited by a shortage of suitable donor organs.
Unfortunately, a third of donated livers cannot be used for transplants, often due to the presence of fat within the liver cells. Transplanting a fatty liver carries a greater risk to the patient compared to a normal liver. This is because fatty livers do not tolerate being cooled down, and we currently store organs in an ice-box before the transplant.
An alternative new technology, called normothermic machine perfusion (NMP), stores the liver in very similar conditions to those in the body: it maintains the liver at body temperature and provides oxygen and nutrition. Evidence confirms that NMP preserves the liver in a better condition, with less damage to liver cells. It also allows the surgeon to test how well the organ is working before deciding whether to carry out the transplant.
Whilst beneficial, NMP technology does not completely resolve the problem of fatty livers because fat remains in the liver cells. To assess this problem, in this clinical 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.
What does this study hope to find
We aim to assess how many of the 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. In addition, 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.
It is important to understand that the livers in this study are not discarded organs; they are organs that have been retrieved for the intent of transplantation and you would have been offered this liver whether or not you agree to take part in the study.
More information
If you have any questions for the researchers or would like further information, please do feel free to get in touch with the research team by emailing DeFat@nhsbt.nhs.uk.