跳至主要内容
临床试验/NCT06749990
NCT06749990招募中不适用

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
320
试验地点
1
主要终点
alcohol relapse rate

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Major psychopathologies and active psychoses

结局指标

主要结局

alcohol relapse rate

时间窗: 7 years

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

时间窗: 7 years

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

时间窗: 7 years

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

时间窗: 7 years

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

次要结局

  • Impact of alcohol relapse/recurrence on liver transplant outcomes(7 years)
  • Identifying Risk and Protective Factors for Alcohol Relapse(7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验