DCN for ECD Livers

• Conditions: Liver Transplantation

• Registration Number: NCT06804746
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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)

Detailed Description

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 Timeline

• Study Start: 2019-03-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Adult patients (>18 years old)
• Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.

Exclusion Criteria

• Multiorgan transplantation
• Split liver transplant
• Living donor liver transplantation
• Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death-censored graft survival	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.

Secondary Outcome Measures

Name	Time	Method
• Overall graft survival	1 year post-transplant	Time from liver transplantation until re-transplantation or all-cause death.
Overall patient survival	1 year post-transplant	Time from liver transplantation until all-cause death
Number of participants with primary non function	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).
Occurrence of hepatic arterial thrombosis	1 year post-transplant	Radiologically or surgically proven thrombosis of the hepatic artery.
Occurrence of portal vein thrombosis	1 year post-transplant	Radiologically or surgically proven thrombosis of the portal vein.
Occurrence of venous outflow tract obstruction	1 year post-transplant	Radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava.
Occurrence of non-anastomotic biliary strictures	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).
Occurrence of anastomotic biliary strictures	1 year post-transplant	Strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb.
Occurrence of biliary leakage	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).
Biliary complications: as a composite	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.
Intensive care stay	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
Total hospital stay	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

Trial Locations

Locations (2)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands