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Completed

NCT Number: NCT04964687

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

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.

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Key information

Conditions

Alcoholism Adenocarcinoma Alcohol Use Disorder Alcohol-Induced Disorders Alcohol-Related Disorders Alcohol; Liver Carcinoma Carcinoma, Hepatocellular Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Diseases, Alcoholic Liver Neoplasms Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Transplantation

Procedure

Liver transplantation

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. Rate of development of cardiovascular risk factors

    Time frame: 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

    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.

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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