DHOPE-DCD Trial
Research type
Research Study
Full title
A Multicentre Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion with Standard Static Cold Storage of Liver Grafts Donated after Circulatory Death in Preventing Non-anastomotic Biliary Strictures after Transplantation
IRAS ID
228359
Contact name
Nigel Heaton
Contact email
Sponsor organisation
University Medical Center Groningen
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 28 days
Research summary
Shortage of liver grafts for orthotopic liver transplant has increasingly resulted in the use of livers of marginal quality. This could be either (A) livers that carry a high risk of technical complications and impaired function (i.e. elderly donors, steatotic donors or split livers) and (B) grafts that carry a risk of transmission of infection or malignancy to the recipient (i.e. donor with viral infections or donors with malignancy). In either case, patients experience poor outcomes post transplant and this is often due to complications.
Non-anastomotic biliary strictures (NAS) are a major complication that has been seen in 29% of patients receiving livers obtained after circulatory death (DCD) as opposed to 11% of patients receiving livers after brain death (DBD). Ischaemia (after static cold storage – SCS – which is the method used to preserve the liver during transfer) and reperfusion injury has been associated with the development of NAS.
Machine perfusion is a dynamic perfusion strategy that offers the opportunity to improve the quality of the donated liver; providing oxygen and nutrients to the tissue. Experimental studies have shown that 1-2 hours of hypothermic (at 12 degrees Celsius) oxygenated perfusion of DCD liver grafts (termed DHOPE) after SCS not only improves organ integrity and function after reperfusion but also significantly increases survival after transplantation.
This RCT has been designed to investigate hypothesis that end-ischemic DHOPE after SCS is a better method for preservation of the biliary tree resulting in a lower incidence of symptomatic NAS after DCD liver transplantation than SCS alone. Machine perfusion will be done by the Liver Assist device.
Patients who are due to undergo a transplant using DCD livers will be approached, and randomised to standard care or study intervention (DHOPE). Tissue and perfusate samples will be taken peri-operatively to investigate the molecular development of tissue injury.REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/2011
Date of REC Opinion
17 Jan 2018
REC opinion
Further Information Favourable Opinion