Is Access to Liver Transplantation Similar in Alcoholic or Not Patients?

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01820819

Acronym

TRANSALC

Enrollment

574

Registered

2013-03-29

Start date

2012-09-01

Completion date

2016-09-30

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inpatient With End Stage Liver Disease

Keywords

Inpatient, Liver cirrhosis, Liver Cirrhosis, Alcoholic, Physician's Practice Patterns, Liver Transplantation, Delivery of Health Care, Resource Allocation

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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Registration on the national waiting list	3 years

Secondary

Measure	Time frame	Description
Potential candidate to liver transplantation according to the opinion of the caring physician on	At Day 0	At the time of inpatients inclusion (previous study: fifth year after the first inclusion)

Countries

France

Contacts

STUDY_DIRECTORYvon Calmus, MD, PhD

Paris-Est University, AP-HP

Outcome results