• Rianne van Rijn, Aad P van den Berg, Joris I Erdmann, Nigel Heaton, Bart van Hoek, Jeroen de Jonge, Leuvenink Henri G D HGD Surgical Research Laboratory, Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands., Shekar V K Mahesh, Sarah Mertens, Diethard Monbaliu, Paolo Muiesan, Perera M Thamara P R MTPR Liver Unit, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Wojciech G Polak, Xavier Rogiers, Roberto I Troisi, Yvonne de Vries, and Robert J Porte.
• Section Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.
• Bmc Gastroenterol. 2019 Mar 12; 19 (1): 40.

BackgroundThe major concern in liver transplantation of grafts from donation after circulatory death (DCD) donors remains the high incidence of non-anastomotic biliary strictures (NAS). Machine perfusion has been proposed as an alternative strategy for organ preservation which reduces ischemia-reperfusion injury (IRI). Experimental studies have shown that dual hypothermic oxygenated machine perfusion (DHOPE) is associated with less IRI, improved hepatocellular function, and better preserved mitochondrial and endothelial function compared to conventional static cold storage (SCS). Moreover, DHOPE was safely applied with promising results in a recently performed phase-1 study. The aim of the current study is to determine the efficacy of DHOPE in reducing the incidence of NAS after DCD liver transplantation.MethodsThis is an international multicenter randomized controlled trial. Adult patients (≥18 yrs. old) undergoing transplantation of a DCD donor liver (Maastricht category III) will be randomized between the intervention and control group. In the intervention group, livers will be subjected to two hours of end-ischemic DHOPE after SCS and before implantation. In the control group, livers will be subjected to care as usual with conventional SCS only. Primary outcome is the incidence of symptomatic NAS diagnosed by a blinded adjudication committee. In all patients, magnetic resonance cholangiography will be obtained at six months after transplantation.DiscussionDHOPE is associated with reduced IRI of the bile ducts. Whether reduced IRI of the bile ducts leads to lower incidence of NAS after DCD liver transplantation can only be examined in a randomized controlled trial.Trial RegistrationThe trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283 .

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