Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,343
- 试验地点
- 1
- 主要终点
- Long-term mortality rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023
排除标准
- 未提供
结局指标
主要结局
Long-term mortality rates
时间窗: 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.
Risk factors for mortality
时间窗: 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).
次要结局
- Demographic analysis of transplant recipients(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(1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up)
- Progression of mortality risk factors(1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up)
- Mortality rates(1 year and 5 years post-transplant)
- Liver transplant-specific risk factors(1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up)
- Non-hepatic risk factors for mortality(1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up)