Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 1:30 PM
Study NCT ID:
NCT04961034
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2021-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
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': 'D011171', 'term': 'Portoenterostomy, Hepatic'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the total number of cholangitis', 'timeFrame': 'two years', 'description': 'the total attacks of chollangitis'}, {'measure': 'number of native liver survivors', 'timeFrame': 'two years', 'description': 'the decrease of the need of liver transplantation in children with biliary atresia'}], 'secondaryOutcomes': [{'measure': 'early improvement of liver functions', 'timeFrame': '6 months', 'description': 'normalization of liver function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biliary atresia', 'kasai portoenterostomy', 'modified', 'cholangitis'], 'conditions': ['Biliary Atresia']}, 'descriptionModule': {'briefSummary': 'the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation', 'detailedDescription': 'To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival.\n\nMethods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants with biliary atresia diagnosed and treated before 60th day of age\n\nExclusion Criteria:\n\n* infants older than 60 days'}, 'identificationModule': {'nctId': 'NCT04961034', 'briefTitle': 'Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'orgStudyIdInfo': {'id': '33943/7/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'classic KPE', 'description': 'the classic management of biliary atresia as described', 'interventionNames': ['Procedure: kasai portoenterostomy']}, {'type': 'OTHER', 'label': 'modified KPE', 'description': 'we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis', 'interventionNames': ['Procedure: kasai portoenterostomy']}], 'interventions': [{'name': 'kasai portoenterostomy', 'type': 'PROCEDURE', 'description': 'surgical creation of stoma between porta hepatis and jejunal loop', 'armGroupLabels': ['classic KPE', 'modified KPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'COMPLETED', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '31512', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammad Khirallah', 'role': 'CONTACT', 'email': 'mohamed.khirallah@med.tanta.edu.eg', 'phone': '+201003546853'}], 'facility': 'Tantra Universiy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohammad Khirallah', 'role': 'CONTACT', 'email': 'mohamed.khirallah@med.tanta.edu.eg', 'phone': '+201003546853'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'publication as article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pediatric surgery', 'investigatorFullName': 'Mohammad Gharieb Mohammad Khirallah', 'investigatorAffiliation': 'Tanta University'}}}}