Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial.

van Rijn, Rianne, van den Berg, Aad P, Erdmann, Joris I, Heaton, Nigel, van Hoek, Bart, de Jonge, Jeroen, Leuvenink, Henri G D, Mahesh, Shekar V K, Mertens, Sarah, Monbaliu, Diethard, Muiesan, Paolo, Perera, M Thamara P R, Polak, Wojciech G, Rogiers, Xavier, Troisi, Roberto I, de Vries, Yvonne and Porte, Robert J (2019) Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial. BMC gastroenterology, 19 (1). p. 40. ISSN 1471-230X. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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Abstract

BACKGROUND

The 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.

METHODS

This 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.

DISCUSSION

DHOPE 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 REGISTRATION

The trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283 .

Item Type:	Article
Additional Information:	This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects:	WI Digestive system. Gastroenterology
Divisions:	Planned IP Care > General Surgery
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/?ter...
Depositing User:	Miss Emily Johnson
Date Deposited:	01 Apr 2019 11:20
Last Modified:	01 Apr 2019 11:20
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/1991

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