Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alcohol Related Liver Disease, Orthotopic Liver Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk and Protective Factors for Relapse to Alcohol Use in Patients With Alcohol-related Liver Disease and Undergoing Orthotopic Liver Transplantation
Overview
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.
Primary outcome measures
- alcohol relapse rate [Time frame: 7 years]
- alcohol recurrence rate [Time frame: 7 years]
- Clinical data to assess the risk of alcohol relapse [Time frame: 7 years]
- psychiatric evaluation to assess the risk of alcohol relapse [Time frame: 7 years]
Secondary outcome measures (2)
- Impact of alcohol relapse/recurrence on liver transplant outcomes [Time frame: 7 years]
- Identifying Risk and Protective Factors for Alcohol Relapse [Time frame: 7 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06749990 · RICADUTA