Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diagnostic cholangitis score
研究概览
简要总结
Cholangitis is the most common postoperative complication of biliary atresia, with a reported incidence of 40-90%, which seriously affects the surgical effect, survival rate and the quality of life and prognosis of patients. Without of direct evidence, the diagnosis of cholangitis sometimes is difficult to make, thus most of them are diagnosed based on the symptoms of children. According to literature reports, different centers and regions have different diagnostic criteria for postoperative cholangitis after hepatic portoenterostomy, which has a great influence on the accuracy of the incidence rate and appropriate treatment of cholangitis, and also brings differences in the analysis of the causes and prognostic factors of cholangitis.
Based on the above reasons, we used the Delphi method,in which worldwidely 48 experts participated in, to establish the diagnostic scoring system for postoperative cholangitis after biliary atresia.
Now we aimed to verify the specificity and sensitivity of the new scoring system through clinical cases, in order to unify and standardize the diagnostic criteria and provide help for the diagnosis and treatment of cholangitis after biliary atresia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Admission time: 2019.01.01-2021.12.31;
- •② The first diagnosis after discharge was cholangitis
排除标准
- •① Cholangitis after non-Kasai procedure;
- •Postoperative cholangitis of biliary atresia not operated in the unit; ③ Patient has been treated in other hospitals during this episode; ④ The treatment period for cholangitis is not completed or the patient is discharged automatically.
研究组 & 干预措施
Postoperative cholangitis
Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery
干预措施: Intravenous Antibodies (Drug)
结局指标
主要结局
Diagnostic cholangitis score
时间窗: Two years
The values of the two groups' scores were calculated separately
次要结局
- Score estimates for treatment of cholangitis(Two years)
研究者
Weibing Tang
Dr
Nanjing Children's Hospital
