AlcoholismNCT04964687
Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.
An observational study of Alcoholism and Alcohol Use Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Alcohol Use Disorder, Alcohol; Liver
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 616 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 30 May 2021
- 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: Adult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015. * Saint Eloi University Hospital, University of Montpellier * Edouard Herriot University Hospital, Hospices Civils de Lyon * Rangueil University Hospital, University of Toulouse
Who may be able to join
- adult patients
- who received a liver transplant between January 2000 and December 2015 for alcohol-related liver disease as a primary or secondary indication (hepatocellular carcinoma)
- who survived for more than 6 months after their liver transplant.
Who cannot join
- association of other causes of hepatopathy: viral hepatitis B or C, hereditary hemochromatosis.
- death before discharge from hospital after liver transplantation.
- patient unwilling to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications: a Multicenter Retrospective Comparative Study.
Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.
Read the detailed description
In this observational, retrospective and multicentre study, investigator seek to determine the effect of integrating an addiction team into liver transplantation unit on prognosis of patients with alcohol-related liver disease requiring liver transplantation. Investigatore plan to compare patients in 2 groups, depending on whether they have received or not specific addiction care before and after transplantation. This study was conducted over a period of 15 years in three French liver transplant units.
- Conditions
- Alcoholism, Alcohol Use Disorder, Alcohol; Liver
- Being tested
- Liver transplantation
- Keywords
- transplantation liver, hepatocellular carcinoma, Alcohol
- Medical subject headings
- Alcoholism, Liver Diseases, Alcoholic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Transplanted patients seen by an addictionology team | Adult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015, and seen by an addictology team before and after the transplantation. Receives: Procedure: Liver transplantation | |
| Transplanted patients not seen by an addictionology team | Adult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015, and seen by an addictology team before and after the transplantation. Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of patients transplanted for alcoholic liver disease.
Patient time (delay between date of transplantation and date of last news) + state (alive or deceased)
Measured: Date of last news (at least 5 years for surviving patients)
Secondary outcomes (6)
Alcohol relapse rate
Number of patients with alcohol relapse among all transplanted patients.
Measured: Date of last news (at least 5 years for surviving)
Severe alcohol relapse rate
Number of patients with severe alcohol relapse among all transplanted patients
Measured: Date of last news (at least 5 years for surviving)
Rate of alcohol-related cirrhosis recurrence
Number of patients with alcohol-related cirrhosis among all transplanted patients.
Measured: Date of last news (at least 5 years for surviving)
Rate of development of cardiovascular risk factors
Number of patients developing one or more cardiovascular risk factors (hypertension, dyslipidemia, diabetes, smoking) among all transplanted patients.
Measured: Date of last news (at least 5 years for surviving)
Cardiovascular event rate
Number of patients with one or more cardiovascular events (coronary syndrome, stroke, arterial disease) among all transplant patients.
Measured: Date of last news (at least 5 years for surviving)
De novo cancer-free survival
Number of patients developing de novo cancer as a function of time among all transplanted patients
Measured: Date of last news (at least 5 years for surviving)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Oct 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Donnadieu-Rigole, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964687
- Sponsor's protocol ID
- RECHMPL21_0410
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Daniel J, Dumortier J, Del Bello A, Gamon L, Molinari N, Faure S, Meszaros M, Ursic-Bedoya J, Meunier L, Monet C, Navarro F, Boillot O, Pageaux GP, Donnadieu-Rigole H. Integrating an addiction team into the management of patients transplanted for alcohol-associated liver disease reduces the risk of severe relapse. JHEP Rep. 2023 Jul 30;5(10):100832. doi: 10.1016/j.jhepr.2023.100832. eCollection 2023 Oct.
PubMed 37681206
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications: a Multicenter Retrospective Comparative Study.
- ClinicalTrials.gov ID
- NCT04964687
- Acronym / sponsor ID
- RECHMPL21_0410
- Conditions
- Alcoholism, Alcohol Use Disorder, Alcohol; Liver
- Keywords
- transplantation liver, hepatocellular carcinoma, Alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- 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.
Investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. Our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.
Detailed description
In this observational, retrospective and multicentre study, investigator seek to determine the effect of integrating an addiction team into liver transplantation unit on prognosis of patients with alcohol-related liver disease requiring liver transplantation. Investigatore plan to compare patients in 2 groups, depending on whether they have received or not specific addiction care before and after transplantation. This study was conducted over a period of 15 years in three French liver transplant units.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplanted patients seen by an addictionology team | – | Procedure: Liver transplantationAdult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015, and seen by an addictology team before and after the transplantation. |
| Transplanted patients not seen by an addictionology team | – | Procedure: Liver transplantationAdult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015, and seen by an addictology team before and after the transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with alcohol-related liver disease, possibly complicated by hepatocellular carcinoma, that required liver transplantation in participating centers from January 2000 to December 2015. * Saint Eloi University Hospital, University of Montpellier * Edouard Herriot University Hospital, Hospices Civils de Lyon * Rangueil University Hospital, University of Toulouse
Key inclusion criteria (3 listed)
- adult patients
- who received a liver transplant between January 2000 and December 2015 for alcohol-related liver disease as a primary or secondary indication (hepatocellular carcinoma)
- who survived for more than 6 months after their liver transplant.
Key exclusion criteria (3 listed)
- association of other causes of hepatopathy: viral hepatitis B or C, hereditary hemochromatosis.
- death before discharge from hospital after liver transplantation.
- patient unwilling to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationLiver transplantation | Procedure or surgery | Transplanted patients not seen by an addictionology team, Transplanted patients seen by an addictionology team |
Primary outcome
Overall survival of patients transplanted for alcoholic liver disease.
Time frame: Date of last news (at least 5 years for surviving patients)
Patient time (delay between date of transplantation and date of last news) + state (alive or deceased)
6 secondary outcomes
Alcohol relapse rate
Time frame: Date of last news (at least 5 years for surviving)
Severe alcohol relapse rate
Time frame: Date of last news (at least 5 years for surviving)
Rate of alcohol-related cirrhosis recurrence
Time frame: Date of last news (at least 5 years for surviving)
Rate of development of cardiovascular risk factors
Time frame: Date of last news (at least 5 years for surviving)
Cardiovascular event rate
Time frame: Date of last news (at least 5 years for surviving)
De novo cancer-free survival
Time frame: Date of last news (at least 5 years for surviving)
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 20 Jul 2021.
- Derived from this study: PubMed 37681206Daniel J, Dumortier J, Del Bello A, Gamon L, Molinari N, Faure S, Meszaros M, Ursic-Bedoya J, Meunier L, Monet C, Navarro F, Boillot O, Pageaux GP, Donnadieu-Rigole H. Integrating an addiction team into the management of patients transplanted for alcohol-associated liver disease reduces the risk of severe relapse. JHEP Rep. 2023 Jul 30;5(10):100832. doi: 10.1016/j.jhepr.2023.100832. eCollection 2023 Oct.
- Individual participant dataSharing planned: Undecided. NC
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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.
Hélène Donnadieu-Rigole study director
University Hospital, Montpellier
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 Alcoholism and Alcohol Use Disorder, run by University Hospital, Montpellier 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 20 Jul 2021. 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?
Overall survival of patients transplanted for alcoholic liver disease. (time frame: Date of last news (at least 5 years for surviving patients)). 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 NCT04964687, which also lists 1 linked publication.
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 20 Jul 2021.