Impact of Integrating an Addiction Team on Post Liver Transplantation Survival for Alcohol-related Liver Disease and Its Complications.

Alcohol Use Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964687
• Other study ID #: RECHMPL21_0410
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Liver Diseases

Intervention

Procedure:
• Liver transplantation
Liver transplantation

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alcohol relapse rate	Number of patients with alcohol relapse among all transplanted patients.	Date of last news (at least 5 years for surviving)
Secondary	Severe alcohol relapse rate	Number of patients with severe alcohol relapse among all transplanted patients	Date of last news (at least 5 years for surviving)
Secondary	Rate of alcohol-related cirrhosis recurrence	Number of patients with alcohol-related cirrhosis among all transplanted patients.	Date of last news (at least 5 years for surviving)
Secondary	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.	Date of last news (at least 5 years for surviving)
Secondary	Cardiovascular event rate	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)
Secondary	De novo cancer-free survival	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)