跳至主要内容
临床试验/NCT05848310
NCT05848310招募中不适用

Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Serum total bilirubin level (umol/l)

研究概览

简要总结

To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.

详细描述

Kasai portoenterostomy is currently one of the main treatment methods for biliary atresia, but about 30% of children still require liver transplantation even after receiving the surgery. Accurate prognosis will help select the most suitable treatment method for children, but there is currently a lack of effective preoperative predictive indicators. Serum FGF19 has recently been considered a possible preoperative predictive indicator for biliary atresia, but its predictive value has not been confirmed in a large sample and in Asian population, thus the investigators try to further explore the prognostic value of serum FGF19 in children with biliary atresia based on a large sample.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Samples diagnosed as biliary atresia in Children's Hospital of Fudan University
  • Samples with one-year follow-up records after surgery
  • Samples with a record of serum total bilirubin levels three months after surgery
  • Samples with preoperative serum left(volume > 500ul)

排除标准

  • 未提供

结局指标

主要结局

Serum total bilirubin level (umol/l)

时间窗: Three months after surgery

The difference of serum total bilirubin level will be measured with ELISA( Enzyme Linked ImmunoSorbent Assay) three months after surgery

Native liver survival (%)

时间窗: One year after surgery

The difference of native liver survival will be measured according to the follow-up statue one year after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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