Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-25 @ 6:42 AM
Study NCT ID:
NCT02652533
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Shear Wave Elastography Evaluation of Suspected and Known 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': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2015-12-18', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1)', 'timeFrame': '2 years', 'description': 'The primary outcome measure will be ultrasound shear wave speed of the liver. The investigators will compare the mean liver shear wave speed measurements in children with biliary atresia to other liver diseases. Sensitivity and specificity of ultrasound for diagnosing biliary atresia will be determined using multiple shear wave speed cut-off values.'}], 'secondaryOutcomes': [{'measure': 'Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2)', 'timeFrame': '6 years', 'description': 'Change in shear speed liver over time will be compared between children with biliary atresia versus other liver diseases in order to determine if differences predict important clinical outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Biliary Atresia']}, 'descriptionModule': {'briefSummary': 'The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.', 'detailedDescription': 'The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \\>20% of total or ≥2 mg/dL age \\<3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \\>20% of total or ≥2 mg/dL age \\<3 months\n\nExclusion Criteria:\n\n* inability to obtain parent/guardian consent.\n* inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2).\n* no other exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02652533', 'briefTitle': 'Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia', 'orgStudyIdInfo': {'id': '2015-7320'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound Shear Wave Elastography', 'type': 'DEVICE', 'description': 'The investigators have recently published a very small study in neonates/infants with suspected BA showing that US liver shear wave speed (i.e. - liver stiffness) can differentiate BA from other causes of cholestasis, potentially with a very high degree of accuracy. Additional research is needed to confirm these very preliminary results and determine if liver shear wave speed measurements either before or after (including longitudinally) Kasai can predict key outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital/Stanford University", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jonathan Dillman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens Medical Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}