NCT07582978

Brief Summary

Liver transplantation (LT) is the standard treatment for hepatocellular carcinoma (HCC) and end-stage liver disease, with excellent long-term outcomes despite the increasing use of extended criteria donors due to organ shortage. As traditional evaluation criteria have become insufficient, new indicators such as Arterial and Biliary Complication-Free Survival (ABCFS) have been developed to better assess post-transplant outcomes. Primary objective: To assess, in a large-scale study, whether the procurement technique influences liver transplantation outcomes in terms of arterial and biliary complication-free survival.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,810

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

April 28, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

liver transplantationLThepatocellular carcinoma (HCC)Arterial and Biliary Complication-Free Survivalprocurement technique

Outcome Measures

Primary Outcomes (1)

  • Arterial and Biliary Complication-Free Survival (ABCFS) at 3 years

    at 3 years post-transplantation

Secondary Outcomes (7)

  • Postoperative complications at 90 days

    at 90 days post-transplantation

  • Type of Biliary complications

    Up to 3 years post-transplantation

  • Type of Arterial complications

    Up to 3 years post-transplantation

  • Occurrence of vascular injuries observed following organ procurement

    Peri-procedural period (during procurement and immediately post-procurement)

  • Rehospitalization Rate Post-LT

    Up to 3 years post-transplantation

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients (≥18 years) who undergo a first liver transplantation in France.

You may qualify if:

  • Listed on the national waiting list of the Agence de la Biomédecine (ABM)
  • Undergoing a first liver transplantation in France
  • Receiving a whole liver graft
  • No prior or subsequent transplantation of another organ

You may not qualify if:

  • Pancreas procurement
  • Multiorgan transplantation
  • Split liver transplantation (shared grafts)
  • Retransplantation
  • Domino transplantation (no actual organ procurement in the conventional sense)
  • Patient refusal to allow the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Astrid HERRERO, MD, PhD

    Saint Eloi Hospital, Montpellier University Hospital

    STUDY CHAIR

Central Study Contacts

Eric Savier, MD, PhD

CONTACT

Jinmi BAEK

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share