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

Inpatient With End Stage Liver Disease Clinical Trial

— TRANSALC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820819
• Other study ID #: AOM 10003
• Status: Completed
• Start date: September 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Inpatient With End Stage Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Saint Antoine Hospital (Pr Yvon Camus)

Country where clinical trial is conducted

France, 

References & Publications (5)

Cohen C, Benjamin M. Alcoholics and liver transplantation. The Ethics and Social Impact Committee of the Transplant and Health Policy Center. JAMA. 1991 Mar 13;265(10):1299-301. — View Citation

Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8. Review. — View Citation

Perut V, Conti F, Scatton O, Soubrane O, Calmus Y, Vidal-Trecan G. Might physicians be restricting access to liver transplantation for patients with alcoholic liver disease? J Hepatol. 2009 Oct;51(4):707-14. doi: 10.1016/j.jhep.2009.04.018. Epub 2009 May 28. — View Citation

Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6. — View Citation

Vidal-Trécan G, Kone V, Pilette C, Nousbaum JB, Doll J, Buffet C, Eugene C, Podevin P, Boutet O, Puyeo J, Conti F, Calmus Y. Subjective parameters markedly limit the referral of transplantation candidates to liver transplant centres. Liver Int. 2016 Apr;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration on the national waiting list		3 years
Secondary	Potential candidate to liver transplantation according to the opinion of the caring physician on	At the time of inpatients inclusion (previous study: fifth year after the first inclusion)	At Day 0