Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.
July 19, 2021 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
616
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Montpellier, France, 34295
- Uhmontpellier
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Liver transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Date of last news (at least 5 years for surviving patients)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol relapse rate
Time Frame: Date of last news (at least 5 years for surviving)
|
Number of patients with alcohol relapse among all transplanted patients.
|
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)
|
Number of patients with severe alcohol relapse among all transplanted patients
|
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)
|
Number of patients with alcohol-related cirrhosis among all transplanted patients.
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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)
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Number of patients developing one or more cardiovascular risk factors (hypertension, dyslipidemia, diabetes, smoking) among all transplanted patients.
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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)
|
Number of patients with one or more cardiovascular events (coronary syndrome, stroke, arterial disease) among all transplant patients.
|
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)
|
Number of patients developing de novo cancer as a function of time among all transplanted patients
|
Date of last news (at least 5 years for surviving)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hélène Donnadieu-Rigole, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
May 30, 2021
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 16, 2021
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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