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临床试验/NCT05464303
NCT05464303Unknown不适用

Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy

Nanjing Children's Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Nanjing Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weibing Tang

Dr

Nanjing Children's Hospital

研究点 (1)

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