FIRST BLOOD: this time he's fighting for his liver|
|- candidate number||17065|
|- NTR Number||NTR4483|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2014|
|- Secondary IDs||EMC FBDCDLT V2.0 |
|- Public Title||FIRST BLOOD: this time he's fighting for his liver|
|- Scientific Title||Arterial Reperfusion or Portal Reperfusion First in Liver Transplantation using
Donation after Circulatory Death donors
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Liver transplantation, Donation after Circulatory Death (DCD), Biliary Complications, Hemodynamic Stability|
|- Inclusion criteria||- Age over 18 years of age
- On the active waiting list for liver transplantation
- Foreseen to be offered a donation after circulatory death (DCD) liver graft
- Written informed consent for this trial|
|- Exclusion criteria||- Contra-indications for DCD liver graft
- Split or reduced liver grafts
- Technical contra-indications to arterial reperfusion within 45 minutes (need for vascular reconstructions, jump grafting etc. during warm ischemic period)
- Multi-organ transplantation
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-jan-2017|
|- Target number of participants||150|
|- Interventions||Experimental artery reperfusion first, or standard portal vein reperfusion first in recipients of a DCD donor liver graft|
|- Primary outcome||Occurrence of any biliary complication (leakage, non-anastomotic stricture (NAS) / Ischemia Type Biliary Lesion (ITBL), within the first year post-transplant, for which additional invasive intervention (ERCP, PTC), or drug therapy, other than prescription of ursodeoxicholic acid, is needed.|
|- Secondary outcome||A. Hemodynamic stability at reperfusion, measured as the area under the curve of vasoactive inotropic support in the first hour after reperfusion of the liver graft and the duration of mean arterial blood pressure below 60 mm Hg within the first hour of reperfusion.
B. Incidence of Early Allograft Dysfunction within the first week of liver transplantation, defined by the Olthoff Criteria|
|- Timepoints||Primary objective will be scored at one year after liver tranplantation
Primary objectives will be calculated within the first week after liver transplantation|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| H. Hartog|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J. Jonge, de|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Publications||1. Jay C, Ladner D, Wang E, Lyuksemburg V, Kang R, Chang Y, et al. A comprehensive risk assessment of mortality following donation after cardiac death liver transplant - An analysis of the national registry. J Hepatol. 2011 Oct;55(4):808-13.
2. Jay CL, Lyuksemburg V, Kang R, Preczewski L, Stroupe K, Holl JL, et al. The increased costs of donation after cardiac death liver transplantation: caveat emptor. Ann Surg. 2011 Apr;251(4):743-8.
3. Jay CL, Lyuksemburg V, Ladner DP, Wang E, Caicedo JC, Holl JL, et al. Ischemic cholangiopathy after controlled donation after cardiac death liver transplantation: a meta-analysis. Ann Surg. 2011 Feb;253(2):259-64.
4. Farid WR, de Jonge J, Slieker JC, Zondervan PE, Thomeer MG, Metselaar HJ, et al. The importance of portal venous blood flow in ischemic-type biliary lesions after liver transplantation. Am J Transplant. 2011 Apr;11(4):857-62.|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||31-mrt-2014 - 25-apr-2014|
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