Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06749990

Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation

This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Maria Cristina Morelli

CONTACT

[email protected]

0512144248

About this study

For the retrospective part of the study, clinical data will be collected and analyzed from patients diagnosed with ARLD and with components of exotoxicity who underwent liver transplantation in the past five years. This data will be obtained from patient medical records, including results from laboratory tests and multidisciplinary outpatient consultations conducted as part of routine clinical practice.

The prospective phase of the study will involve the consecutive enrollment of patients diagnosed with ARLD or with exotoxicity-related etiological components who are undergoing liver transplantation at the IRCCS AOUBO. Four patient assessment points are planned, which will take place during routine follow-up visits already scheduled as part of the patient's care pathway. During these visits, data will be collected on the patient's medical history, laboratory and/or histological results, as well as diagnostic and surgical information. Additionally, through the administration of clinical questionnaires, data will be gathered on the patient's psychiatric-psychological status, history of exotoxicity, and psychosocial background.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have signed the informed consent
  • Candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial)
  • For the retrospective part: patients who underwent OLT for ARLD during the time frame 2017-2022

Exclusion criteria

  • Major psychopathologies and active psychoses

Treatment and study plan

Primary outcomes

  1. alcohol relapse rate

    Time frame: 7 years

    To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol relapse rate

  2. alcohol recurrence rate

    Time frame: 7 years

    To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol recurrence rate

  3. Clinical data to assess the risk of alcohol relapse

    Time frame: 7 years

    Collection of clinical data on liver disease through routine visits to assess the risk of alcohol relapse at 12 months post-OLT

  4. psychiatric evaluation to assess the risk of alcohol relapse

    Time frame: 7 years

    Administration of a clinimetric assessment composed of psychometric, self-assessment tests, already validated and widely used in the literature

Secondary outcomes

  1. Impact of alcohol relapse/recurrence on liver transplant outcomes

    Time frame: 7 years

    To assess the impact of alcohol relapse/recurrence on liver transplant outcomes.

  2. Identifying Risk and Protective Factors for Alcohol Relapse

    Time frame: 7 years

    To identify potential risk and protective factors for alcohol relapse and, consequently, to develop a multiparametric/multimodal operational model for evaluating candidates for liver transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Morelli, MD

CONTACT

[email protected]

0512144248

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Risk and Protective Factors for Relapse to Alcohol Use in Patients With Alcohol-related Liver Disease and Undergoing Orthotopic Liver Transplantation

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.