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

This study is currently recruiting participants.
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Saint Antoine Hospital (Pr Yvon Camus)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01820819
First received: March 26, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition
Inpatient With End Stage Liver Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Registration on the national waiting list [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 150
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)
Groups/Cohorts
Registered or not on the transplantation national waiting list

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients aged over 18 admitted to medical or hepato gastroenterology departments of the hospitals selected in three French area with liver cirrhosis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820819

Contacts
Contact: Gwenaëlle Vidal Trécan, MD, PhD +331 58 41 31 46 gwenaelle.vidal-trecan@cch.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Gwenaëlle Vidal Trécan, MD, PhD    +33 1 58 41 31 46    gwenaelle.vidal-trecan@cch.aphp.fr   
Principal Investigator: Gwenaëlle Vidal Trécan, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Saint Antoine Hospital (Pr Yvon Camus)
Investigators
Study Director: Yvon Calmus, MD, PhD Paris-Est University, AP-HP
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01820819     History of Changes
Other Study ID Numbers: AOM 10003
Study First Received: March 26, 2013
Last Updated: August 28, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Inpatient
Liver cirrhosis
Liver Cirrhosis, Alcoholic
Physician's Practice Patterns
Liver Transplantation
Delivery of Health Care
Resource Allocation

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on April 22, 2014