Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-30 @ 4:11 PM
Study NCT ID:
NCT00880633
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2009-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2009-04-13', 'studyFirstSubmitQcDate': '2009-04-13', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EUS', 'periampullary neoplasms'], 'conditions': ['Periampullary Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective review of patients who have already undergone an EUS at this institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.\n* Patients with and without biliary stents will be included.\n\nExclusion Criteria:\n\n* Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.'}, 'identificationModule': {'nctId': 'NCT00880633', 'briefTitle': 'Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review', 'orgStudyIdInfo': {'id': '0703-58'}}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Julia LeBlanc', 'oldOrganization': 'Indiana University'}}}}