In-situ vs Ex-situ Liver Preservation for Transplants
Official title: IN Situ Versus ex Situ Organ PreservatIon: a Randomized Evaluation in the Netherlands (INSPIRE-NL)
Run by Leiden University Medical Center · NCT07899853 · Data updated 2026-11-12
This trial tests whether in-situ aNRP preservation works better than ex-situ DHOPE (with or without COR-NMP) for livers from donors after circulatory death in people awaiting liver transplantation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 752 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 3 sites (Groningen and 2 other locations) |
| Status | Recruiting |
| Started | November 4, 2026 |
| Main results expected | October 1, 2031 |
| Study ends | October 1, 2032 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07899853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (donor age >16) with DCD livers accepted for transplantation in the Netherlands and without logistical or technical constraints to machine perfusion.
✕Probably not a fit
Patients receiving livers not eligible for the studied preservation methods or those with factors that negate potential benefits of machine perfusion may not see improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two liver preservation approaches for transplantation after donation after circulatory death. It assesses whether in-situ normothermic regional perfusion (aNRP) reduces biliary complications at 1 year compared with ex-situ hypothermic oxygenated perfusion (DHOPE), with or without subsequent COR-NMP. Secondary aims include core outcomes, utilization, cost-effectiveness, quality of life, and resource use. The study uses standard clinical practice settings and focuses on DCD livers accepted for transplantation in the Netherlands. Lead center is Leiden University Medical Center with collaboration from ZonMw and other Dutch centers.
Why it matters
Potential benefit: If successful, this approach could reduce biliary complications and improve transplant outcomes while informing best practices and cost-effectiveness for DCD liver preservation.
How similar studies have gone: Previous work has explored aNRP and DHOPE separately, but direct head-to-head comparisons for DCD livers are limited, making this comparative trial relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All DCD donor livers (donor=\>16 years) accepted for transplantation in the Netherlands Exclusion Criteria: * HU recipients * Logistical or technical constraints for machine perfusion
Where it's running
-
University Medical Center Groningen
Groningen, Netherlands Recruiting -
Erasmus Medical Center
Rotterdam, Netherlands Recruiting -
Leiden University Medical Center
Leiden, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Volkert A Huurman, MD PhD — Leiden University Medical Center, Department of Surgery
- Study coordinator: Volkert A Huurman, MD PhD
- Email: v.a.l.huurman@lumc.nl
- Phone: +31-624801027
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.