Definition for Biliary Atresia Associated Cholangitis After Surgery

NCT ID: NCT05464303

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Atresia Cholangitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Postoperative cholangitis

Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery

Intravenous Antibodies

Intervention Type DRUG

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

None postoperative cholangitis

Patients who had conducted kasai procedure and followed up in a clinic,at which time they didn't present signs of cholangitis

No interventions assigned to this group

Interventions

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Intravenous Antibodies

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

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weibing Tang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tang weibing, Dr

Role: STUDY_CHAIR

Nanjing Children's Hospital

Locations

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NJMU

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xie Hua, Dr

Role: CONTACT

+8613611573952

Lu changgui, Dr

Role: CONTACT

+8613611573952

Facility Contacts

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Xie Hua, Dr

Role: primary

+8613611573952

Other Identifiers

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ERBAAC

Identifier Type: -

Identifier Source: org_study_id

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