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

Recruiting

• Conditions: Alcohol Related Liver Disease; Orthotopic Liver Transplantation

• Registration Number: NCT06749990
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2024-01-09
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
alcohol relapse rate	7 years	To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol relapse rate
alcohol recurrence rate	7 years	To describe the population undergoing liver transplantation with a diagnosis of ARLD and exotoxicity-related components in terms of alcohol recurrence rate
Clinical data to assess the risk of alcohol relapse	7 years	Collection of clinical data on liver disease through routine visits to assess the risk of alcohol relapse at 12 months post-OLT
psychiatric evaluation to assess the risk of alcohol relapse	7 years	Administration of a clinimetric assessment composed of psychometric, self-assessment tests, already validated and widely used in the literature

Secondary Outcome Measures

Name	Time	Method
Impact of alcohol relapse/recurrence on liver transplant outcomes	7 years	To assess the impact of alcohol relapse/recurrence on liver transplant outcomes.
Identifying Risk and Protective Factors for Alcohol Relapse	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

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy