The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are: * Death censored graft-survival * Overall patient survival * Frequency of frequent post-transplant complications (e.g. non-anastomotic biliary strictures)
With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.
Study Type
OBSERVATIONAL
Enrollment
143
Resuscitation and viability assessment through the previously published protocol of sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate.
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Death-censored graft survival
Time from liver transplantation until re-transplantation or death due to graft dysfunction, with censoring of subjects who died with a functioning graft.
Time frame: 1 year post-transplant
Overall patient survival
Time from liver transplantation until all-cause death
Time frame: 1 year post-transplant
• Overall graft survival
Time from liver transplantation until re-transplantation or all-cause death.
Time frame: 1 year post-transplant
Number of participants with primary non function
Livers failing to sustain their primary function, leading to death or re-transplantation within 7 days of the primary procedure, in the presence of patent blood supply and outflow (8).
Time frame: From transplantation until 7 days post-transplant
Occurrence of hepatic arterial thrombosis
Radiologically or surgically proven thrombosis of the hepatic artery.
Time frame: 1 year post-transplant
Occurrence of portal vein thrombosis
Radiologically or surgically proven thrombosis of the portal vein.
Time frame: 1 year post-transplant
Occurrence of venous outflow tract obstruction
Radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava.
Time frame: 1 year post-transplant
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Occurrence of non-anastomotic biliary strictures
Any irregularity or narrowing of the lumen of the intrahepatic or extrahepatic donor bile ducts, excluding the biliary anastomosis, diagnosed with the use of cholangiography in combination with clinical symptoms (e.g., jaundice or cholangitis) or an elevation of cholestatic laboratory variables, in the presence of a patent hepatic artery (5).
Time frame: 1 year post-transplant
Occurrence of anastomotic biliary strictures
Strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb.
Time frame: 1 year post-transplant
Occurrence of biliary leakage
Fluid with an elevated (\>3x serum) bilirubin level in the abdominal drain or intra-abdominal fluid on or after post-operative day 3 or the need for radiological intervention (i.e. interventional drainage) owing to biliary collections or re-laparotomy due to biliary peritonitis (9).
Time frame: From 3 days after transplantation until the the first year post-transplant
Biliary complications: as a composite
A composite of individually studied outcome measures (reported as one single outcome measure), composed of: non-anastomotic biliary strictures, anastomotic biliary strictures and biliary leakage.
Time frame: 1 year post-transplant
Intensive care stay
Intensive care stay post-transplantation
Time frame: From transplantation until discharge from the Intensive care unit to the ward after transplantation or date of death from any cause during initial admission, whichever came first, assessed up to 6 months
Total hospital stay
Defined as total hospital stay from transplantation until discharge, including intensive care unit stay
Time frame: From transplantation until discharge after transplantation, or date of death from any cause during initial admission, whichever came first, assessed up to 6 months