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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04964687
Collaborator
(none)
616
1
19.9
30.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Liver transplantation

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

Study Type:
Observational
Actual Enrollment :
616 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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.
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm 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.

Procedure: Liver 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.

Procedure: Liver transplantation
Liver transplantation

Outcome Measures

Primary Outcome Measures

  1. Overall survival of patients transplanted for alcoholic liver disease. [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)

Secondary Outcome Measures

  1. Alcohol relapse rate [Date of last news (at least 5 years for surviving)]

    Number of patients with alcohol relapse among all transplanted patients.

  2. Severe alcohol relapse rate [Date of last news (at least 5 years for surviving)]

    Number of patients with severe alcohol relapse among all transplanted patients

  3. Rate of alcohol-related cirrhosis recurrence [Date of last news (at least 5 years for surviving)]

    Number of patients with alcohol-related cirrhosis among all transplanted patients.

  4. Rate of development of cardiovascular risk factors [Date of last news (at least 5 years for surviving)]

    Number of patients developing one or more cardiovascular risk factors (hypertension, dyslipidemia, diabetes, smoking) among all transplanted patients.

  5. Cardiovascular event rate [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.

  6. De novo cancer-free survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Study Director: Hélène Donnadieu-Rigole, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04964687
Other Study ID Numbers:
  • RECHMPL21_0410
First Posted:
Jul 16, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021