Is Access to Liver Transplantation Similar in Alcoholic or Not Patients?
NCT ID: NCT01820819
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
574 participants
OBSERVATIONAL
2012-09-30
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Registered or not on the transplantation national waiting list
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Age less to 18
* With acute liver failure or hepatocarcinoma without liver cirrhosis
18 Years
ALL
No
Sponsors
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Saint Antoine Hospital (Pr Yvon Camus)
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Yvon Calmus, MD, PhD
Role: STUDY_DIRECTOR
Paris-Est University, AP-HP
Locations
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Cochin Hospital
Paris, , France
Countries
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References
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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.
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. doi: 10.1001/jama.265.10.1299.
Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8.
Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6.
Vidal-Trecan 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;36(4):555-62. doi: 10.1111/liv.13030. Epub 2015 Dec 21.
Other Identifiers
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AOM 10003
Identifier Type: -
Identifier Source: org_study_id
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