Идёт набор NCT06749990

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

— Наблюдательное Alcohol Related Liver Disease Orthotopic Liver Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Alcohol Related Liver Disease, Orthotopic Liver Transplantation. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Первичные конечные точки

alcohol relapse rate [Срок оценки: 7 years]
alcohol recurrence rate [Срок оценки: 7 years]
Clinical data to assess the risk of alcohol relapse [Срок оценки: 7 years]
psychiatric evaluation to assess the risk of alcohol relapse [Срок оценки: 7 years]

Вторичные конечные точки (2)

Impact of alcohol relapse/recurrence on liver transplant outcomes [Срок оценки: 7 years]
Identifying Risk and Protective Factors for Alcohol Relapse [Срок оценки: 7 years]

Критерии участия

Критерии включения

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