Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04319302
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2020-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015529', 'term': 'Choledochal Cyst'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': '1 year', 'description': 'What were the long term complications'}], 'primaryOutcomes': [{'measure': 'Bile drainage', 'timeFrame': '30 days', 'description': 'Effectiveness of procedure to allow drainage of bile into the bowel.'}], 'secondaryOutcomes': [{'measure': 'Complications of procedure', 'timeFrame': '30 days', 'description': 'What complications were encountered following the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Choledochal cyst', 'Paediatric', 'Roux-en-Y', 'Bile drainage', 'Gastric conduit'], 'conditions': ['Biliary Obstruction', 'Choledochal Cyst']}, 'descriptionModule': {'briefSummary': 'This was a retrospective case series experience of paediatric patients who had an Isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. We reviewed our experience and outcomes.', 'detailedDescription': 'Background\n\nDespite the enormous surgical advancements in the last century, access to the biliary system is lost when a Roux-en-Y (RY) biliary drainage procedure is performed. Attempts have been made to overcome this inconvenient sequel of RY biliary drainage by the use of variations in the RY anastomosis, small bowel grafts and vascular grafts. These have been predominantly unsuccessful. The use of an Isolated Vascularized Gastric Tube (IVGT) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. The investigators have adopted the technique of using an IVGT graft for bile duct reconstruction in the paediatric patients at their institution.\n\nMethod\n\nThe investigators reviewed theirr experience at Greys Hospital, Pietermaritzburg. This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. The investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective review of all paediatric patients at Greys Hospital who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients from birth to 12 years with biliary tract obstruction requiring surgery.\n\nExclusion Criteria:\n\n* biliary atresia'}, 'identificationModule': {'nctId': 'NCT04319302', 'briefTitle': 'Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.', 'organization': {'class': 'OTHER', 'fullName': 'University of KwaZulu'}, 'officialTitle': 'Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.', 'orgStudyIdInfo': {'id': 'C3619112712050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paediatric biliary obstruction', 'description': 'This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. We looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.', 'interventionNames': ['Procedure: Isolated Vascularized Gastric Tube (IVGT) graft']}], 'interventions': [{'name': 'Isolated Vascularized Gastric Tube (IVGT) graft', 'type': 'PROCEDURE', 'description': 'A conduit was created by tubularising a vascularized segment of the greater curve of the antrum of the stomach and this was used between the remaining common hepatic duct and the duodenum.', 'armGroupLabels': ['Paediatric biliary obstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3201', 'city': 'Pietermaritzburg', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Greys Hospital', 'geoPoint': {'lat': -29.61679, 'lon': 30.39278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be retained by researchers and ade available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of KwaZulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Paediatric Surgery, Greys Hospital', 'investigatorFullName': 'Hansraj Mangray', 'investigatorAffiliation': 'University of KwaZulu'}}}}