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临床试验/NCT01820819
NCT01820819已完成不适用

Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
574
试验地点
1
主要终点
Registration on the national waiting list

研究概览

简要总结

The purpose of this study is to determine whether there are reasons other than medical reasons that could limit access to liver transplantation in alcoholic patients.

详细描述

The investigators perform a study combining the follow up of a previous cohort of 450 patients and the inclusion of 150 new patients.

The study is performed in medical or hepatogastroenterology departments of nine French public hospitals mostly non-teaching. They lay in three French area, selected according to the density of patients with alcoholic liver disease (ALD) in the area, respectively, "high" as in Brittany-Loire, 'average' in Ile de France and "low" as in the Languedoc-Roussillon.

The patients included in the cohort must respond to the following criteria: having liver cirrhosis of whatever origin and age over 18 years. The cirrhosis must be confirmed by the morphological or histological criteria.

Structured forms and questionnaires will allow the collection of data. Information collected from patients include socio demographic characteristics, medical history, history of consumption of psychotropic (i.e., alcohol or drugs), clinical, biological, histological characteristics and psychological. Inpatients complete a self-assessment structured questionnaire "Hospital Anxiety Depression Scale" (HAD).

Patients are followed until they are registered or not on the national waiting list or die, every 6 months after inclusion until 2 years.

研究设计

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

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

  • Inpatients
  • Age over 18
  • Having liver cirrhosis of whatever origin (Cirrhosis was confirmed if morphological or histological criteria with or without esophageal varicoses were met)

排除标准

  • Outpatients
  • Age less to 18
  • With acute liver failure or hepatocarcinoma without liver cirrhosis

研究组 & 干预措施

Registered or not on the transplantation national waiting list

结局指标

主要结局

Registration on the national waiting list

时间窗: 3 years

次要结局

  • Potential candidate to liver transplantation according to the opinion of the caring physician on(At Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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