Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-04 @ 3:45 PM
Study NCT ID:
NCT01908868
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2013-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-26', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '18 months', 'description': 'The primary outcome is the diagnostic yield of the procedure defined as demonstration of granulomatous inflammation in two groups in patients finally labelled as sarcoidosis'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '18 months', 'description': 'Occurrence of serious adverse events (pneumothorax, bleeding \\>100 ml, death) in the two groups'}, {'measure': 'Diagnostic yield of individual sampling techniques', 'timeFrame': '18 months', 'description': 'To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '24481031', 'type': 'DERIVED', 'citation': 'Gupta D, Dadhwal DS, Agarwal R, Gupta N, Bal A, Aggarwal AN. Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014 Sep;146(3):547-556. doi: 10.1378/chest.13-2339.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.', 'detailedDescription': 'Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. In the past, TBLB has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of EBUS. We have observed that EBUS even though has high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.\n\nThe study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nConsecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration\n\nExclusion Criteria:\n\n* Pregnancy\n* Hypoxemia (SpO2 \\<90%) on room air\n* Poor lung function (forced expiratory volume in first second \\[FEV1\\] \\<1L)\n* Patients with deranged clotting profile (prothrombin time \\>3 seconds above control; activated partial thromboplastin time \\>10 seconds above control, platelet count \\<50000/µL)\n* Patients already initiated on glucocorticoids\n* Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01908868', 'briefTitle': 'A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'orgStudyIdInfo': {'id': '1Trg/PG-2012/12563-601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBUS-TBNA', 'description': 'EBUS-TBNA (with endobronchial and transbronchial lung biopsy)', 'interventionNames': ['Other: EBUS-TBNA', 'Other: Endobronchial and transbronchial biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional TBNA', 'description': 'Conventional TBNA (with endobronchial and transbronchial lung biopsy)', 'interventionNames': ['Other: Conventional TBNA', 'Other: Endobronchial and transbronchial biopsy']}], 'interventions': [{'name': 'EBUS-TBNA', 'type': 'OTHER', 'description': 'Mediastinal and hilar lymph node aspiration using endobronchial ultrasound', 'armGroupLabels': ['EBUS-TBNA']}, {'name': 'Conventional TBNA', 'type': 'OTHER', 'description': 'Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration', 'armGroupLabels': ['Conventional TBNA']}, {'name': 'Endobronchial and transbronchial biopsy', 'type': 'OTHER', 'description': 'Endobronchial and transbronchial lung biopsy using flexible bronchoscopy', 'armGroupLabels': ['Conventional TBNA', 'EBUS-TBNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Chest Clinic, PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ritesh Agarwal', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}