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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Major psychopathologies and active psychoses

Trial population

The patients in the retrospective cohort include those diagnosed with ARLD and exotoxicity-related components who underwent liver transplantation and were followed at the Internal Medicine Department for the treatment of severe organ failure at IRCCS AOUBO between 01/01/2017 and 31/12/2022. The patients in the prospective cohort are those diagnosed with ARLD or with exotoxicity-related etiologies who are referred to the Internal Medicine Department for the treatment of severe organ failure.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

alcohol relapse rate

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

Time frame
7 years
2

alcohol recurrence rate

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

Time frame
7 years
3

Clinical data to assess the risk of alcohol relapse

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

Time frame
7 years
4

psychiatric evaluation to assess the risk of alcohol relapse

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

Time frame
7 years

Secondary outcomes

1

Impact of alcohol relapse/recurrence on liver transplant outcomes

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

Time frame
7 years
2

Identifying Risk and Protective Factors for Alcohol Relapse

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

Time frame
7 years

Other outcomes

Sponsors and contacts

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