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AFP Model and Liver Transplantation.

NCT03775863 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2018-12-19

No results posted yet for this study

Summary

Background \& Aim: Presence of microvascular invasion (mvi) in the explanted liver defines a higher risk of recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT). The aim of this study is to evaluate pre LT selection models of HCC recurrence specifically in patients without mvi in the explanted liver.

Methods: Three multicenter cohorts are going to be included: a Latin American, a French and an Italian cohort of consecutive adult patients with HCC a first LT performed during two different periods: 2005-2011 and 2012-2016. AFP model is going to be compared against Milan and San Francisco criteria according to each models accuracy and prediction of HCC recurrence among patients without microvascular invasion in the explanted liver considering these candidates as "Low-risk patients". Multivariate Cox regression analysis, with hazard ratios (HR) and 95% confidence intervals (CI) for 5-year recurrence is going to be done with Competing Risk Regression analysis and corresponding Subhazard Ratios (SHR).

Conditions

  • Liver Carcinoma
  • Liver Transplant Disorder

Interventions

PROCEDURE

Liver transplantation

Liver transplantation for patients with hepatocellular carcinoma

Sponsors & Collaborators

  • Austral University, Argentina

    lead OTHER

Principal Investigators

  • Federico Piñero, MD, MSCE · Austral University, Argentina

  • Christophe Duvoux, MD · Henri Mondor Hospital, University of Paris-Est, Creteil, France.

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-11
Primary Completion
2018-12-12
Completion
2018-12-12

Countries

  • Argentina
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775863 on ClinicalTrials.gov