Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-02 @ 12:09 AM
Study NCT ID:
NCT05464303
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definition for Biliary Atresia Associated Cholangitis After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}, {'id': 'D002761', 'term': 'Cholangitis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic cholangitis score', 'timeFrame': 'Two years', 'description': "The values of the two groups' scores were calculated separately"}], 'secondaryOutcomes': [{'measure': 'Score estimates for treatment of cholangitis', 'timeFrame': 'Two years', 'description': 'In the cholangitis group, the correlation between evaluation score and treatment was studied'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Atresia', 'Cholangitis']}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.\n\nNow 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had been conducted Kasai procedure have different outcomes. The clinical data of these patients who were diagnosed as cholangitis and were followed up in the clinic were collected in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n① Admission time: 2019.01.01-2021.12.31;\n\n② The first diagnosis after discharge was cholangitis\n\nExclusion Criteria:\n\n① Cholangitis after non-Kasai procedure;\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT05464303', 'briefTitle': 'Definition for Biliary Atresia Associated Cholangitis After Surgery', 'organization': {'class': 'OTHER', 'fullName': "Nanjing Children's Hospital"}, 'officialTitle': 'Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy', 'orgStudyIdInfo': {'id': 'ERBAAC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative cholangitis', 'description': 'Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery', 'interventionNames': ['Drug: Intravenous Antibodies']}, {'label': '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"}], 'interventions': [{'name': 'Intravenous Antibodies', 'type': 'DRUG', 'description': 'Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results', 'armGroupLabels': ['Postoperative cholangitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xie Hua, Dr', 'role': 'CONTACT', 'email': 'xiehua3955@126.com', 'phone': '+8613611573952'}], 'facility': 'NJMU', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xie Hua, Dr', 'role': 'CONTACT', 'email': 'xiehua3955@126.com', 'phone': '+8613611573952'}, {'name': 'Lu changgui, Dr', 'role': 'CONTACT', 'phone': '+8613611573952'}], 'overallOfficials': [{'name': 'Tang weibing, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "Nanjing Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nanjing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Weibing Tang', 'investigatorAffiliation': "Nanjing Children's Hospital"}}}}