FIRST BLOOD: this time he's fighting for his liver

Rationale: Liver transplantation with a donor organ from a donation after circulatory death (DCD donor, carries a much higher risk on biliary complications, with subsequently increased risk for decreased graft survival and need for re-transplantation. Different sequences of revascularizing the dual blood supply to the liver may affect warm ischemia times and thus the severity of ischaemia-reperfusion injury to the biliary tree.
Objective: We seek to decrease the number of biliary complications with 50% by connecting the hepatic artery first, compared to standard portal venous reconstruction first, in DCD liver transplantation.
Study design: We propose to randomize 150 recipients of a DCD donor liver graft in 4 collaborating international transplant centers between two different surgical techniques of organ reperfusion: experimental artery reperfusion first, or standard portal vein first. The trial is patient-blinded.
Study population: All recipients of a DCD donor liver graft, after obtaining written informed consent, will be enrolled and randomized per-operatively to either surgical technique.
Intervention: Experimental artery reperfusion first, or standard portal vein reperfusion first in recipients of a DCD donor liver graft
Main study parameters/endpoints: The primary endpoint is the total amount of biliary complications, including interventions (ERCP/PTC) and re-transplantation within the first year after transplantation. Secondary end-points will be hemodynamic stability during the reperfusion phase and the incidence of early allograft dysfunction (EAD) in the first week after liver transplantation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: So far, three small studies on sequence of liver graft revascularizion, showed no differences in biliary complications and retransplantation rates between the study groups, but DCD donor grafts were not included in this studies. Retrospective pilot results from our partner QE Hospital in Birmingham, showed lower peak AST and bilirubin levels after initial arterial reperfusion, ensuring safety of concept. Regardless of sequence of intraoperative vascular anastomosis, all patients will be follow-up according to local protocol. Extra burden for the patients in this research is to undergo non-invasive MRCP at one year of FU. Expected benefits are reduced biliary complications requiring invasive medical procedures, such as ERCP, PTC with biliary dilatation, or re-transplantation.

Liver transplantation with a donor organ from a donation after circulatory death (DCD donor, carries a much higher risk on biliary complications, with subsequently increased risk for decreased graft survival and need for re-transplantation. Different sequences of revascularizing the dual blood supply to the liver may affect warm ischemia times and thus the severity of ischaemia-reperfusion injury to the biliary tree. We seek to decrease the number of biliary complications with 50% by connecting the hepatic artery first, compared to standard portal venous reconstruction first, in DCD liver transplantation.

Primary objective will be scored at one year after liver tranplantation
Primary objectives will be calculated within the first week after liver transplantation

Experimental artery reperfusion first, or standard portal vein reperfusion first in recipients of a DCD donor liver graft