Clinical trial NCT06636409: Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.
Official title: Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Transplant
Keywords: Mortality
Risk factors
Decompensated chronic liver diseases
Survival
Immunosuppression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 1343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had liver transplant between 2008 and 2013

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Long-term mortality rates
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
measure: Risk factors for mortality
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Secondary outcomes:
measure: Demographic analysis of transplant recipients
timeFrame: Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
measure: Factors influencing mortality rates
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
measure: Progression of mortality risk factors
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
measure: Mortality rates
timeFrame: 1 year and 5 years post-transplant
measure: Liver transplant-specific risk factors
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
measure: Non-hepatic risk factors for mortality
timeFrame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Saint Eloi, CHU de Montpellier
Study officials:
affiliation: Saint Eloi-Hospital, Montpellier
name: Magdalena MESZAROS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
citation: Dopazo C, Bilbao I, Castells LL, Sapisochin G, Moreiras C, Campos-Varela I, Echeverri J, Caralt M, Lazaro JL, Charco R. Analysis of adult 20-year survivors after liver transplantation. Hepatol Int. 2015 Jul;9(3):461-70. doi: 10.1007/s12072-014-9577-x. Epub 2014 Sep 18.