NCT Number: NCT06804746
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)
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Notify Me18 year and older
All sexes
Observational
University Medical Center Groningen, Groningen, Provincie Groningen, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year post-transplant
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
Time from liver transplantation until all-cause death
Time frame: 1 year post-transplant
Time from liver transplantation until re-transplantation or all-cause death.
Time frame: From transplantation until 7 days post-transplant
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: 1 year post-transplant
Radiologically or surgically proven thrombosis of the hepatic artery.
Time frame: 1 year post-transplant
Radiologically or surgically proven thrombosis of the portal vein.
Time frame: 1 year post-transplant
Radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava.
Time frame: 1 year post-transplant
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
Strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb.
Time frame: From 3 days after transplantation until the the first year post-transplant
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: 1 year post-transplant
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: 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
Intensive care stay post-transplantation
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
Defined as total hospital stay from transplantation until discharge, including intensive care unit stay
Time frame: Until 6 months after liver transplantation
The occurrence and frequency of the composite of one of the following biliary interventions (reported as one single outcome measure): Endoscopic Retrograde Cholangio- and Pancreaticography, drainage performed by percutaneous transhepatic cholangiography and re-interventions for biliary complications (e.g. bile leaks)
Erasmus Medical Center
Other
Safe Transplantation of Extended Criteria Donor Livers: Two-center Experience With Resuscitation and Viability Assessment of 206 Livers Using Sequential Hypo- and Normothermic Machine Perfusion
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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