Clinical trial NCT06804746: DCN for ECD Livers
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Transplantation
Keywords: Liver Transplantation
Machine Perfusion
Extended Criteria Donors
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2025-02-03
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) undergoing liver transplantation of extended criteria donor livers, which therefore required resuscitation and viability assessment through the previously published DHOPE-COR-NMP protocol based on a blood-based perfusate.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Death-censored graft survival
timeFrame: 1 year post-transplant
Secondary outcomes:
measure: Overall patient survival
timeFrame: 1 year post-transplant
measure: • Overall graft survival
timeFrame: 1 year post-transplant
measure: Number of participants with primary non function
timeFrame: From transplantation until 7 days post-transplant
measure: Occurrence of hepatic arterial thrombosis
timeFrame: 1 year post-transplant
measure: Occurrence of portal vein thrombosis
timeFrame: 1 year post-transplant
measure: Occurrence of venous outflow tract obstruction
timeFrame: 1 year post-transplant
measure: Occurrence of non-anastomotic biliary strictures
timeFrame: 1 year post-transplant
measure: Occurrence of anastomotic biliary strictures
timeFrame: 1 year post-transplant
measure: Occurrence of biliary leakage
timeFrame: From 3 days after transplantation until the the first year post-transplant
measure: Biliary complications: as a composite
timeFrame: 1 year post-transplant
measure: Intensive care stay
timeFrame: 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
measure: Total hospital stay
timeFrame: From transplantation until discharge after transplantation, or date of death from any cause during initial admission, whichever came first, assessed up to 6 months
Other outcomes:
measure: Composite of post-transplant incidence of biliary interventions
timeFrame: Until 6 months after liver transplantation
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
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citation: van Leeuwen OB, de Vries Y, Fujiyoshi M, Nijsten MWN, Ubbink R, Pelgrim GJ, Werner MJM, Reyntjens KMEM, van den Berg AP, de Boer MT, de Kleine RHJ, Lisman T, de Meijer VE, Porte RJ. Transplantation of High-risk Donor Livers After Ex Situ Resuscitation and Assessment Using Combined Hypo- and Normothermic Machine Perfusion: A Prospective Clinical Trial. Ann Surg. 2019 Nov;270(5):906-914. doi: 10.1097/SLA.0000000000003540.
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