Definition for Biliary Atresia Associated Cholangitis After Surgery

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464303
• Other study ID #: ERBAAC
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Nanjing Children's Hospital
• Contact: Xie Hua, Dr
• Phone: +8613611573952
• Email: xiehua3955[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

? Admission time: 2019.01.01-2021.12.31;

? The first diagnosis after discharge was cholangitis

Exclusion Criteria:

? Cholangitis after non-Kasai procedure;

• Postoperative cholangitis of biliary atresia not operated in the unit; ? Patient has been treated in other hospitals during this episode; ? The treatment period for cholangitis is not completed or the patient is discharged automatically.

Related Conditions & MeSH terms

• Biliary Atresia
• Cholangitis

Intervention

Drug:
• Intravenous Antibodies
Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results

Locations

Country	Name	City	State
China	NJMU	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic cholangitis score	The values of the two groups' scores were calculated separately	Two years
Secondary	Score estimates for treatment of cholangitis	In the cholangitis group, the correlation between evaluation score and treatment was studied	Two years