Liver transplantation Surgery
Conditions
Interventions
Once the centre accepts the liver for their recipient, and the potential recipient has consented to be part of the study, the donor livers will be randomised (50/50) between two arms: the comparator a
Sponsors
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Donor livers: 1. Whole livers 2. Donor family consent for research 3. Donor aged 18 years or over 4. Liver donated after circulatory death, including livers donated by Maastricht IV donors (donation after treatment withdrawal in a patient previously diagnosed dead by neurological criteria) Liver transplant recipient: 1. Recipients 18 years of age and above 2. On the liver transplant waiting list at a participating centre, awaiting a liver transplant 3. Participant must have capacity to provide written informed consent to the trial. Where capacity is subsequently lost, the research team must seek the views of a consultee
Exclusion criteria
Exclusion criteria: Donor livers: 1. Livers recovered using in situ normothermic regional perfusion 2. Livers preserved with ex situ hypothermic oxygenated perfusion 3. Livers donated after brain death, excluding Maastricht IV donors 4. Split or partial liver grafts 5. Donor is HIV positive 6. Liver transplanted outside one of the trial participating centres 7. Livers subject to traumatic injury at the time of death which has stopped bleeding but which may start with the infusion of alteplase 8. Participating centre (or alternative participating centre with capacity for NMP) cannot offer NMP due to device, logistical or staffing issues Liver transplant recipients: 1. Recipient is a multiorgan recipient (excluding liver + kidney) 2. There are foreseeable contraindications for recipient to have an MRCP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of transplanted randomised livers where symptomatic non- anastomotic biliary strictures are confirmed by a cholangiogram with agreement between at least two radiographers by 6 months post-transplant (+/- 2 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Graft and patient survival between intervention and comparator groups will be measured using: 1.1. Proportion of transplanted livers with primary non-function: defined as graft failure resulting in death or retransplantation within 14 days after transplantation, excluding hepatic artery thrombosis, biliary complication, recurrent disease or acute rejection. 1.2. Graft survival proportion estimated at 3 and 6 months following transplantation (defined as a functioning transplant in the absence of retransplantation and censored for death). 1.3. Transplant survival proportion estimated at 3 and 6 months following transplantation (graft survival not censored for death – i.e. defined as a surviving recipient with a functioning transplant in the absence of retransplantation). 1.4. Patient survival proportion estimated at 3 and 6 months following transplantation. 2. Biochemical liver function between intervention and comparator groups will be measured using: 2.1. Mean biochemical liver function (ALP, ALT/AST, INR, Bilirubin) at days 1 to 7 and months 3 and 6 following transplantation. 2.2. Early allograft function measured via Olthoff criteria and MEAF score. Olthoff criteria uses the day 7 bilirubin and INR value and day 1-7 ALT or AST values. The MEAF score is calculated using the day 1-3 ALT and INR values and the day 3 bilirubin value. 3. Biliary complications beyond the primary outcome between groups will be measured using: 3.1. Proportion of transplanted livers with symptomatic (requiring intervention) anastomotic strictures by 6 months (+/2 months) post-transplant confirmed by MRCP (or ERCP/PTC if done for clinical reasons). 3.2. Proportion of transplanted livers with asymptomatic anastomotic or non-anastomotic strictures at 6 months (+/2 months) post-transplant confirmed by MRCP, excluding those related to hepatic artery thrombosis. 3.3. Proportion of transplanted livers with bile leaks requiring stenting or surgery during post-transplantation in-patient stay or | — |
Countries
England, United Kingdom
Outcome results
None listed