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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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
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
Secondary outcomes
Impact of alcohol relapse/recurrence on liver transplant outcomes
To assess the impact of alcohol relapse/recurrence on liver transplant outcomes.
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
Sponsors and contacts
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