Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT06447051
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-08', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We expect steroids used in customized manner to improve biliary drainage and thereby improve native liver survival in post kasai patients.', 'timeFrame': 'Within 6 months'}], 'secondaryOutcomes': [{'measure': 'Improved survival with native liver at 12 months of age.', 'timeFrame': '12 months'}, {'measure': 'Reduced progression of portal Hypertension at 6 & 12 months', 'timeFrame': '6 & 12 months'}, {'measure': 'Improved Growth parameters at 3, 6, 12 months', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Reduction in Bilirubin levels at 3, 6, 12 month', 'timeFrame': '3, 6, 12 months'}, {'measure': 'Reduced PELD at 3, 6, 12 months', 'timeFrame': '3, 6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Atresia']}, 'descriptionModule': {'briefSummary': 'Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation \\[1\\]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level \\<2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States \\[2\\]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents \\[3,4\\]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect \\[5\\].\n\nIn 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation \\[6\\]. Since then there have been multiple trial most prominent being, Kings hospital trial \\[7\\] and START trial \\[8\\] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival.\n\nHowever one study done by Bezerra et al \\[9\\] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.', 'detailedDescription': 'Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).\n\nStudy design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study.\n\nMonitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year.\n\nStatistical Analysis: Appropriate statistical test for correlation analysis will be applied.\n\nAdverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post Kasai Biliary atresia operated at ILBS with retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).\n\nExclusion Criteria:\n\n1. Subjects having major surgical complications\n2. Defaulters or Patient not following protocol/not giving consent\n3. Biliary atresia splenic malformation'}, 'identificationModule': {'nctId': 'NCT06447051', 'briefTitle': 'Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.', 'orgStudyIdInfo': {'id': 'ILBS-Biliary Atresia-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biliary Atresia', 'description': 'Subject undergoing Kasai Surgery at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).', 'interventionNames': ['Other: Kasai Surgery']}], 'interventions': [{'name': 'Kasai Surgery', 'type': 'OTHER', 'description': 'As per institute treatment protocol', 'armGroupLabels': ['Biliary Atresia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Anmol, MD', 'role': 'CONTACT', 'email': 'dranmol1991@gmail.com', 'phone': '01146300000'}], 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dr Anmol Anmol, MD', 'role': 'CONTACT', 'email': 'dranmol1991@gmail.com', 'phone': '01146300000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}