Clinical trial NCT04964687: Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Alcohol Use Disorder
Alcohol; Liver
Keywords: transplantation liver
hepatocellular carcinoma
Alcohol
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival of patients transplanted for alcoholic liver disease.
timeFrame: Date of last news (at least 5 years for surviving patients)
Secondary outcomes:
measure: Alcohol relapse rate
timeFrame: Date of last news (at least 5 years for surviving)
measure: Severe alcohol relapse rate
timeFrame: Date of last news (at least 5 years for surviving)
measure: Rate of alcohol-related cirrhosis recurrence
timeFrame: Date of last news (at least 5 years for surviving)
measure: Rate of development of cardiovascular risk factors
timeFrame: Date of last news (at least 5 years for surviving)
measure: Cardiovascular event rate
timeFrame: Date of last news (at least 5 years for surviving)
measure: De novo cancer-free survival
timeFrame: Date of last news (at least 5 years for surviving)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Hélène Donnadieu-Rigole
role: STUDY_DIRECTOR
References: