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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Orthotopic Liver Transplantation; Alcohol Related Liver Disease

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 Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Maria Cristina Morelli, MD; Phone Number: 0512144248; Email: mariacristina.morelli@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Maria Cristina Morelli; Phone Number: 0512144248; Email: mariacristina.morelli@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 years
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	7 years
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	7 years
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	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of alcohol relapse/recurrence on liver transplant outcomes	To assess the impact of alcohol relapse/recurrence on liver transplant outcomes.	7 years
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	7 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Maria Cristina Morelli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: RICADUTA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No