Clinical trial NCT06749990: Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation
Official title: Risk and Protective Factors for Relapse to Alcohol Use in Patients With Alcohol-related Liver Disease and Undergoing Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Related Liver Disease
Orthotopic Liver Transplantation
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: alcohol relapse rate
timeFrame: 7 years
measure: alcohol recurrence rate
timeFrame: 7 years
measure: Clinical data to assess the risk of alcohol relapse
timeFrame: 7 years
measure: psychiatric evaluation to assess the risk of alcohol relapse
timeFrame: 7 years
Secondary outcomes:
measure: Impact of alcohol relapse/recurrence on liver transplant outcomes
timeFrame: 7 years
measure: Identifying Risk and Protective Factors for Alcohol Relapse
timeFrame: 7 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria Cristina Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References: