Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-22 @ 3:17 PM
Study NCT ID:
NCT01467635
Status:
WITHDRAWN
Last Update Posted:
2016-07-13
First Post:
2011-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS-TBNA Versus EBUS-TBNB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Manufacturer did not develop and deliver the necessary biopsy forceps needles in time', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.', 'timeFrame': '18 months', 'description': 'The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:\n\n* Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.\n* Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.\n* Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.'}], 'secondaryOutcomes': [{'measure': 'The difference in the complication rate between the two study arms', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endobronchial ultrasound', 'Transbronchial needle aspiration', 'Transbronchial biopsy forceps', 'Mediastinal lymphadenopathy', 'Hilar lymphadenopathy'], 'conditions': ['Mediastinal Lymphadenopathy', 'Hilar Lymphadenopathy', 'Carcinoma', 'Lymphoma', 'Sarcoidosis', 'Mycobacterial Disease']}, 'descriptionModule': {'briefSummary': 'A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).\n\nThe study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for EBUS-TBNA as part of clinical care\n* Lymph nodes larger than 10mm in diameter\n* Age \\> 18 years\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)\n* Inability to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT01467635', 'briefTitle': 'EBUS-TBNA Versus EBUS-TBNB', 'organization': {'class': 'OTHER', 'fullName': 'Royal Brompton & Harefield NHS Foundation Trust'}, 'officialTitle': 'Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial', 'orgStudyIdInfo': {'id': '2011PA002B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EBUS-TBNA', 'description': 'Sampling using endobronchial ultrasound guided transbronchial needle aspiration', 'interventionNames': ['Device: Endobronchial ultrasound guided lymph node sampling']}, {'type': 'EXPERIMENTAL', 'label': 'EBUS-TBNB', 'description': 'Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.', 'interventionNames': ['Device: Endobronchial ultrasound guided lymph node sampling']}], 'interventions': [{'name': 'Endobronchial ultrasound guided lymph node sampling', 'type': 'DEVICE', 'otherNames': ['Olympus EBUS-TBNA needle', 'Olympus EBUS-TBNB biopsy forceps'], 'description': 'Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.', 'armGroupLabels': ['EBUS-TBNA', 'EBUS-TBNB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Zaid Zoumot, MBBS, MRCP, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust'}, {'name': 'Pallav L Shah, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}