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Expansion of criteria for liver transplants in malignant liver diseases: A policy-oriented analysis within the Eurotransplant network

Expansion of criteria for liver transplants in malignant liver diseases: A policy-oriented analysis within the Eurotransplant network - EXPAND-LT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039498
Enrollment
140000
Registered
2026-03-03
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C22.0 C22.1 C24.0 C78.7 K72.9 K70 K74 K83.0 K75.4 E83.1 E83.0

Interventions

Group 1: Retrospective registry-based analysis of all adult patients listed for primary liver transplantation within the Eurotransplant network between 2007 and 2024, irrespective of underlying indica

Sponsors

Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
Lead Sponsor
Chirurgie Innsbruck
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Registration in the Eurotransplant liver waiting list registry within the observation period 01/2007–12/2024 • Available listing date and defined waitlist outcome (transplantation, death, or delisting) • Documented primary diagnosis allowing classification into oncologic or non-oncologic indication • Availability of MELD score (laboratory or exception MELD) at time of listing • Assignable Eurotransplant member country

Exclusion criteria

Exclusion criteria: • Age < 18 years at the time of listing • Listing for combined or multi-organ transplantation (e.g. liver-kidney, liver-heart) • Missing information on key time variables (listing date or event date) • Missing assignment of a waiting list event (transplant, death or delisting) • Unclear or unclassifiable primary diagnosis • Duplicate registrations of the same listing process • Listing outside the defined observation period

Design outcomes

Primary

MeasureTime frame
Change in waitlist mortality resulting from a modeled expansion of liver transplantation eligibility criteria to selected hepatic malignancies. Waitlist mortality will be calculated as deaths per 1,000 patient-years using competing-risk methodology (transplantation and delisting as competing events) and compared between the current allocation scenario and simulated expanded-criteria scenarios.

Secondary

MeasureTime frame
1. Change in median time to transplantation across MELD strata and diagnostic groups. 2. Probability of transplantation within defined time intervals using competing risk methodology (death or delisting as competing events). 3. Estimated transplant benefit for newly eligible oncologic patient groups compared with the remaining waitlist population. 4. Changes in organ availability and allocation dynamics (proportion transplanted, delisting due to clinical deterioration). 5. Regional differences within the Eurotransplant network regarding waitlist mortality, transplant probability, and minimally required post-transplant survival thresholds. 6. Sensitivity analyses to determine the minimal acceptable 5-year post-transplant survival at which no relevant disadvantage to the existing waitlist population occurs.

Countries

Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, Netherlands, Slovenia

Contacts

Public ContactRupert Oberhuber

Chirurgie Innsbruck

rupert.oberhuber@i-med.ac.at+43 512 504 22600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026