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

Sarah Mertens¹  Diethard Monbaliu¹  Bart van Hoek²  Aad P. van den Berg³  Shekar V. K. Mahesh⁴  Wojciech G. Polak⁵  Jeroen de Jonge⁵  Joris I. Erdmann⁶  Roberto I. Troisi⁷  Xavier Rogiers⁷  Nigel Heaton⁸  Paolo Muiesan⁹  M. Thamara P. R. Perera⁹  Yvonne de Vries^1,10  Robert J. Porte^1,10  Rianne van Rijn^1,10  Henri G. D. Leuvenink^1,11 

[1] Department of Abdominal Transplantation Surgery, University Hospitals of Leuven;Department of Gastroenterology and Hepatology, Leiden University Medical Center;Department of Gastroenterology and Hepatology, University Medical Center Groningen;Department of Radiology, University Medical Center Groningen;Department of Surgery, Erasmus University Medical Center;Department of Surgery, Leiden University Medical Center;Department of Transplant Surgery, Ghent University Hospital;Institute of Liver Studies, Kings College Hospital NHS Foundation Trust;Liver Unit, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust;Section Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen;Surgical Research Laboratory, Department of Surgery, University Medical Center Groningen;

关键词: Donation after circulatory death;    Adult;    Incidence;    Ischemic type biliary lesions;    Survival;    Cost;   

DOI  :  10.1186/s12876-019-0956-6

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown