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Definition for Biliary Atresia Associated Cholangitis After Surgery

N

Nanjing Children's Hospital

Status

Enrolling

Conditions

Cholangitis
Biliary Atresia

Treatments

Drug: Intravenous Antibodies

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Postoperative cholangitis
Description:
Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery
Treatment:
Drug: Intravenous Antibodies
None postoperative cholangitis
Description:
Patients who had conducted kasai procedure and followed up in a clinic,at which time they didn't present signs of cholangitis

Trial contacts and locations

1

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Central trial contact

Xie Hua, Dr; Lu changgui, Dr

Data sourced from clinicaltrials.gov

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