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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06636409
Enrollment
1343
Registered
2024-10-10
Start date
2023-08-01
Completion date
2028-08-01
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Keywords

Mortality, Risk factors, Decompensated chronic liver diseases, Survival, Immunosuppression

Brief summary

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.

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.

Interventions

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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Long-term mortality rates1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upEvaluation of overall mortality rates among liver transplant recipients, measured from the time of transplantation until the end of the follow-up period.
Risk factors for mortality1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upIdentification 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

MeasureTime frameDescription
Progression of mortality risk factors1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upMeasurement of how mortality risk factors evolve over time after liver transplantation, focusing on conditions like diabetes, hypertension, renal dysfunction, cardiovascular diseases and graft complications
Mortality rates1 year and 5 years post-transplantAssessment of mortality rates specifically at the 1-year and 5-year post-transplant milestones to evaluate early and mid-term survival outcomes.
Demographic analysis of transplant recipientsBaseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upAnalysis 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
Non-hepatic risk factors for mortality1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upAssessment 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
Liver transplant-specific risk factors1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upDetermination 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
Factors influencing mortality rates1 year, 5 years, and 10 years post-transplant, as well as at the last follow-upInvestigation of specific factors contributing to mortality rates, such as pre-existing liver disease, metabolic conditions and immunosuppressive therapy, in liver transplant recipients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026