NCT06636409

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,343 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2028-07-30
• Completion: 2028-08-01
• First posted: 2024-10-10
• Last updated: 2024-10-10

Locations

1 site across 1 country: France