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