Is Access to Liver Transplantation Similar in Alcoholic o... | NCT01820819

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

NCT01820819

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Feb 13, 2026Actual

Enrollment

574Actual

Phase

Not provided

Conditions

Inpatient With End Stage Liver Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012Actual

Primary Completion Date

Sep 30, 2016Actual

Completion Date

Sep 30, 2016Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Mar 28, 2013

First Posted Date

Mar 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2026

Last Update Posted Date

Feb 13, 2026Actual

Name	Class
Saint Antoine Hospital (Pr Yvon Camus)	UNKNOWN
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

574Actual

Label	Type	Description	Intervention Names
Registered or not on the transplantation national waiting list

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Registration on the national waiting list		3 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yvon Calmus, MD, PhD	Paris-Est University, AP-HP	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cochin Hospital		Paris		75014	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19665248	Background	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.
1995978	Background	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.

ID	Term
D008103	Liver Cirrhosis
D008104	Liver Cirrhosis, Alcoholic

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes