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Definition for Biliary Atresia Associated Cholangitis After Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05464303
Enrollment
500
Registered
2022-07-19
Start date
2022-07-15
Completion date
2022-12-31
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Cholangitis

Brief 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.

Interventions

DRUGIntravenous Antibodies

Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results

Sponsors

Nanjing Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

① Admission time: 2019.01.01-2021.12.31; ② The first diagnosis after discharge was cholangitis

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic cholangitis scoreTwo yearsThe values of the two groups' scores were calculated separately

Secondary

MeasureTime frameDescription
Score estimates for treatment of cholangitisTwo yearsIn the cholangitis group, the correlation between evaluation score and treatment was studied

Countries

China

Contacts

Primary ContactXie Hua, Dr
xiehua3955@126.com+8613611573952
Backup ContactLu changgui, Dr
+8613611573952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026