Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? (TRANSALC)
Inpatient With End Stage Liver Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study|
- Registration on the national waiting list [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Potential candidate to liver transplantation according to the opinion of the caring physician on [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]At the time of inpatients inclusion (previous study: fifth year after the first inclusion)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
|Registered or not on the transplantation national waiting list|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820819
|Paris, France, 75014|
|Study Director:||Yvon Calmus, MD, PhD||Paris-Est University, AP-HP|