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NCT Number: NCT06636409

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Transplant

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Eloi, CHU de Montpellier

Montpellier, 34090, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Collection of medical data

Other

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

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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