Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.

October 9, 2024 updated by: University Hospital, Montpellier
Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. This study does not interfere with patients' medical care. The study method involves collecting and analyzing only the essential data from patient records.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Liver transplantation stands as the gold standard for treating decompensated chronic liver diseases and select cases of hepatocellular carcinoma. Over time, post-transplant survival rates have shown consistent improvement, attributed to advancements in surgical techniques, refined immunosuppressive protocols, and enhanced comprehension of post-transplant complications. These developments have significantly mitigated the incidence of infectious, immunological, and neoplastic complications following transplantation.

Research indicates post-liver transplant survival rates of approximately 85% at one year, 68% at five years, and 50% at ten years. It is important to note that these statistics are based on patients transplanted in the 1990s, whose immunosuppression relied on a combination of cyclosporine, azathioprine, and corticosteroids.

The field of immunosuppression has undergone substantial evolution, with an expansion in therapeutic options. These include the gradual replacement of Cyclosporine A with Tacrolimus, and the introduction of interleukin-2 receptor inhibitors, mycophenolate mofetil, and mTOR inhibitors. These innovations facilitate more adaptable protocols, offering improved preservation of renal function and allowing for earlier discontinuation of corticosteroids. As a result, these new therapeutic options offer immunosuppression that is more tailored to each patient, with reduced long-term toxicity.

The primary objective of this study is to investigate long-term mortality rates following liver transplantation and to identify the various risk factors contributing to mortality in these patients, with a particular focus on the current era of immunosuppression techniques. This investigation will be conducted within the framework of a French multicentric cohort study.

The results of this study have the potential to enhance our understanding of long-term post-transplant mortality and to more accurately identify risk factors. This knowledge could inform the refinement of immunosuppressive treatments and post-transplant patient care protocols. The overarching aim of this research is to optimize the management of liver transplant recipients and ultimately prolong their survival.

Study Type

Observational

Enrollment (Estimated)

1343

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

  • France
      • Montpellier, France, 34090
        • Saint Eloi, CHU de Montpellier

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had liver transplant between 2008 and 2013

Description

Inclusion Criteria:

  • Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023

Exclusion Criteria:

-

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
Liver transplant patients
Liver transplant patients from all French centers between 2008 and 2013 and followed up during the period 2008-2023.
Other: Collection of medical data
A randomised selection of files to be analyzed will be conducted in each center to constitute a representative sample of liver transplanted patients. This represents 20% of the number of transplanted patients over the period 2008-2013 in the center, allowing a more in-depth analysis of the patients' medical records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term mortality rates
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Evaluation of overall mortality rates among liver transplant recipients, measured from the time of transplantation until the end of the follow-up period.
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Risk factors for mortality
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Identification of pre- and post-transplant risk factors associated with long-term mortality in liver transplant recipients. Risk factors include demographics (age, sex), comorbidities (diabetes, hypertension, cardiovascular diseases), and transplant-specific factors (MELD score, graft function).
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic analysis of transplant recipients
Time Frame: Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Analysis of the demographic characteristics (age, gender, BMI, lifestyle factors such as diabetes, cardiovascular diseases, dyslipidemia, tobacco/alcohol use) of transplant recipients between 2008 and 2013 to determine trends and associations with outcomes
Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Factors influencing mortality rates
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Investigation of specific factors contributing to mortality rates, such as pre-existing liver disease, metabolic conditions and immunosuppressive therapy, in liver transplant recipients
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Progression of mortality risk factors
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Measurement of how mortality risk factors evolve over time after liver transplantation, focusing on conditions like diabetes, hypertension, renal dysfunction, cardiovascular diseases and graft complications
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Mortality rates
Time Frame: 1 year and 5 years post-transplant
Assessment of mortality rates specifically at the 1-year and 5-year post-transplant milestones to evaluate early and mid-term survival outcomes.
1 year and 5 years post-transplant
Liver transplant-specific risk factors
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Determination of transplant-specific risk factors, including graft rejection, graft dysfunction, recurrence of primary liver disease, and the need for re-transplantation, associated with post-transplant mortality
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Non-hepatic risk factors for mortality
Time Frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Assessment of non-hepatic risk factors associated with post-transplant mortality, encompassing metabolic conditions (such as obesity, hypertension, and diabetes), cardiovascular and renal complications, extra-hepatic malignancies, and infectious diseases
1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Magdalena MESZAROS, MD, Saint Eloi-Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2023

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL19_0432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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