Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.
1 other identifier
observational
616
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedFirst Submitted
Initial submission to the registry
July 6, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedJuly 20, 2021
July 1, 2021
1.7 years
July 6, 2021
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Date of last news (at least 5 years for surviving patients)
Secondary Outcomes (6)
Alcohol relapse rate
Date of last news (at least 5 years for surviving)
Severe alcohol relapse rate
Date of last news (at least 5 years for surviving)
Rate of alcohol-related cirrhosis recurrence
Date of last news (at least 5 years for surviving)
Rate of development of cardiovascular risk factors
Date of last news (at least 5 years for surviving)
Cardiovascular event rate
Date of last news (at least 5 years for surviving)
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Liver transplantation
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
Related Publications (1)
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.
PMID: 37681206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hélène Donnadieu-Rigole
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2021
First Posted
July 16, 2021
Study Start
October 1, 2019
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
July 20, 2021
Record last verified: 2021-07