Inpatient With End Stage Liver DiseaseTRANSALCNCT01820819
Is Access to Liver Transplantation Similar in Alcoholic or Not Patients?
An observational study of Inpatient With End Stage Liver Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inpatient With End Stage Liver Disease
- How many people
- 574 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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)
Who cannot join
- Outpatients
- Age less to 18
- With acute liver failure or hepatocarcinoma without liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Inpatient With End Stage Liver Disease
- Keywords
- Inpatient, Liver cirrhosis, Liver Cirrhosis, Alcoholic, Physician's Practice Patterns, Liver Transplantation, Delivery of Health Care, Resource Allocation
- Medical subject headings
- Liver Cirrhosis, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Registered or not on the transplantation national waiting list | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration on the national waiting list
Measured: 3 years
Secondary outcomes (1)
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)
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startSep 2012
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inpatient With End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Antoine Hospital (Pr Yvon Camus), URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yvon Calmus, MD, PhD, Study director, Paris-Est University, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820819
- Sponsor's protocol ID
- AOM 10003
- Acronym
- TRANSALC
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2013
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19665248Cohen 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.
PubMed 1995978Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8.
PubMed 1524600Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6.
PubMed 9346761Vidal-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.
PubMed 26604165
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01820819
- Acronym / sponsor ID
- TRANSALC / AOM 10003
- Conditions
- Inpatient With End Stage Liver Disease
- Keywords
- Inpatient, Liver cirrhosis, Liver Cirrhosis, Alcoholic, Physician's Practice Patterns, Liver Transplantation, Delivery of Health Care, Resource Allocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Saint Antoine Hospital (Pr Yvon Camus), URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2012 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registered or not on the transplantation national waiting list | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Outpatients
- Age less to 18
- With acute liver failure or hepatocarcinoma without liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Registration on the national waiting list
Time frame: 3 years
1 secondary outcome
Potential candidate to liver transplantation according to the opinion of the caring physician on
Time frame: At Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 19665248Perut 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.
- Background: PubMed 1995978Cohen 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.
- Background: PubMed 1524600Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8.
- Background: PubMed 9346761Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6.
- Results publication: PubMed 26604165Vidal-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvon Calmus, MD, PhD study director
Paris-Est University, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inpatient With End Stage Liver Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration on the national waiting list (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820819, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.