Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-30 @ 6:55 AM
Study NCT ID:
NCT02977650
Status:
UNKNOWN
Last Update Posted:
2016-11-30
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of bleeding adverse events', 'timeFrame': 'Within 2 weeks'}], 'secondaryOutcomes': [{'measure': 'The rate of thromboembolic events', 'timeFrame': 'Within 2 weeks'}, {'measure': 'The rate of other adverse events', 'timeFrame': 'Within 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endoscopic Ultrasonography-guided Fine Needle Aspiration']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients taking anticoagulants who underwent EUS-FNA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Taking anticoagulants\n* Written informed consent\n\nExclusion Criteria:\n\n* Platelets count less than 50000/μl\n* PT-INR more than 2.6\n* ASA more than 3\n* Severe bleeding tendency'}, 'identificationModule': {'nctId': 'NCT02977650', 'briefTitle': 'EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge', 'organization': {'class': 'NETWORK', 'fullName': 'Hokkaido Pancreatobiliary Endoscopic Intervention Study Group'}, 'officialTitle': 'EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge', 'orgStudyIdInfo': {'id': '016-0040'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic ultrasonography-guided fine needle aspiration', 'type': 'PROCEDURE', 'otherNames': ['EUS-FNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0608638', 'city': 'Sapporo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazumichi Kawakubo', 'role': 'CONTACT', 'email': 'kkawakubo-gi@umin.ac.jp', 'phone': '117161161'}], 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}], 'centralContacts': [{'name': 'Kazumichi Kawakubo, Ph.D.', 'role': 'CONTACT', 'email': 'kkawakubo-gi@umin.ac.jp', 'phone': '117161161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hokkaido Pancreatobiliary Endoscopic Intervention Study Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Kazumichi Kawakubo', 'investigatorAffiliation': 'Hokkaido Pancreatobiliary Endoscopic Intervention Study Group'}}}}