"Assessment of the Histological Evolution of Pediatric Patients With Liver Transplantation"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sublcinical inflamation
研究概览
简要总结
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations (inflammation or fibrosis) in protocol biopsies.
The objective of the study was to evaluate the histological findings of protocol biopsies performed at 2, 5, 10 and 15 years after liver transplantation in pediatric patients. A follow-up biopsy is also performed 1 and 3 years after liver rejection.
To do that, a cohort study will be carried out by collecting clinical, analytical and histological data of patients undergoing post-liver transplant follow-up in pediatric hepatology and liver transplant outpatient clinics. According to the follow-up protocol for these patients, a liver biopsy is performed at 2, 5, 10 and 15 years after the transplant. In addition, ultrasound, elastography and general analysis with autoimmunity and HLA studies are carried out.
The evaluation of the histological evolution of the liver graft and its relationship with clinical and analytical changes will favor the management of immunosuppressive treatment in pediatric patients with liver transplants.
详细描述
Given the increase in survival of both the graft and the transplanted patient, new questions arise regarding long-term follow-up. In general, transplant patients undergo follow-up visits that include blood tests and abdominal ultrasounds. Immunosuppression levels, graft function and possible complications (infectious, tumorous, acute or chronic rejection, renal) are monitored.
The use of immunosuppressants is mainly associated with renal, infectious complications and de novo cancer. However, insufficient levels of immunosuppression can lead to graft rejection. On the one hand, various authors have attempted to completely withdraw immunosuppressive treatment in selected patients. On the other hand, histological alterations have been evidenced in patients with normal liver function tests and who maintained serum levels of immunosuppression in the therapeutic range. The balance between these two situations in not always easy.
Hypothesis:
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations (inflammation or fibrosis) in protocol biopsies.
Main objetive:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 2-18 years old who have received a liver transplant at least two years ago
- •Follow-up in pediatric hepatology and liver transplant outpatient clinics at the Vall d'Hebron Hospital
- •Performing tests, ultrasound, elastography and biopsy during the last year as part of the follow-up protocol of our center
- •Patients who have signed the informed consent for inclusion in the study and the corresponding assents.
排除标准
- •Patients who do not meet all the inclusion criteria of the protocol.
- •Patients who are transplant recipients of multiple solid organs.
结局指标
主要结局
Sublcinical inflamation
时间窗: From 15 March 2019 to 31 december 2024
Patients with normal liver function tests and RAI \> 2 in the follow-up liver biopsy
次要结局
- Fibrosis(From 15 March 2019 to 31 december 2024)
- Sublcinical inflamation modification(From 15 March 2020 to 31 december 2024)
研究者
Jesús Quintero
Lead Clinician; Pediatric Hepatology and Liver Transplant Department
Hospital Vall d'Hebron