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Clinical Trials/NCT01820819
NCT01820819CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country574 target enrollmentStarted: September 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
574
Locations
1
Primary Endpoint
Registration on the national waiting list

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Arms & Interventions

Registered or not on the transplantation national waiting list

Outcomes

Primary Outcomes

Registration on the national waiting list

Time Frame: 3 years

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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