Overview

This trial is active, not recruiting.

Condition inpatient with end stage liver disease
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Saint Antoine Hospital (Pr Yvon Camus)
Start date September 2012
End date September 2017
Trial size 115 participants
Trial identifier NCT01820819, AOM 10003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Registration on the national waiting list
time frame: 3 years

Secondary Outcomes

Measure
Potential candidate to liver transplantation according to the opinion of the caring physician on
time frame: At Day 0

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study
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. Statistical analysis will focus on descriptive analysis, survival analysis by Kaplan-Meier, and analytic analysis. Association with registration on the national waiting list of inpatients will be searched using Cox and logistic regression models. Further analyzes will be conducted for example on the differences of opinion between physicians and patients, on regional differences.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.