Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 7:24 PM
Study NCT ID:
NCT05311150
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017565', 'term': 'Sarcoidosis, Pulmonary'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012507', 'term': 'Sarcoidosis'}, {'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', 'maskingDescription': 'The pathologist analyzing the biopsy specimen will be masked.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-03-26', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis', 'timeFrame': '7 days', 'description': 'Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)'}], 'secondaryOutcomes': [{'measure': 'Complications: Bleeding', 'timeFrame': '1 day', 'description': 'The incidence of bleeding after the endobronchial biopsy'}, {'measure': 'Procedure duration', 'timeFrame': '1 day', 'description': 'Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoidosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '41026031', 'type': 'DERIVED', 'citation': 'Rathi K, Dogra P, Agarwal R, Singh Sehgal I, Muthu V, Thurai Prasad K, Aggarwal AN, Bal A, Gupta N, Dhooria S. A randomized trial of narrow band imaging for performing airway mucosal biopsy in pulmonary sarcoidosis (NABS). Sarcoidosis Vasc Diffuse Lung Dis. 2025 Sep 30;42(3):16418. doi: 10.36141/svdld.v42i3.16418.'}]}, 'descriptionModule': {'briefSummary': 'In the diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (NBI) bronchoscopy. The present study aims to compare the diagnostic yield of endobronchial biopsyperformed under direct narrow band imaging or white light bronchoscopy guidance in suspected sarcoidosis.We hypothesize that the use of NBI will improve the yield of endobronchial biopsy in patients with sarcoidosis.', 'detailedDescription': 'The present study will be a randomized controlled trial. It will be performed in the Bronchoscopy suite of the Department of Pulmonary Medicine, PGIMER. Subjects meeting the selection criteria will be randomized 1:1 to undergo EBB under real-time visualization with NBI or white light bronchoscopy. The randomization sequence will be computer generated and the study group allocations will be placed in opaque sealed envelopes. They will be opened just before the performance of the bronchoscopic procedures.\n\nPrimary outcome:the diagnostic yield of EBB (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)\n\nSecondary outcomes:\n\n1. Complications related to the procedure (bleeding)\n2. Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than 18 years.\n2. Clinical presentation and radiological findings (enlarged hilar and or mediastinal lymph nodes \\>10 mm \\[short axis\\], and/or perilymphatic nodules or peribronchovascular thickening on computed tomography \\[CT\\] chest) suggesting sarcoidosis.\n3. Willing to give informed consent.\n\nExclusion Criteria:\n\n1. Hemodynamic instability (systolic BP \\<100 mm Hg).\n2. Pregnancy.\n3. Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.\n4. Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.'}, 'identificationModule': {'nctId': 'NCT05311150', 'acronym': 'NABS', 'briefTitle': 'An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'A Randomized Control Trial to Compare the Diagnostic Yield of Endobronchial Biopsy Performed Under Direct Narrow Band Imaging or White Light Bronchoscopy Guidance in Suspected Sarcoidosis', 'orgStudyIdInfo': {'id': 'INT/IEC/2021/SPL-1817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Narrow band imaging bronchoscopy', 'description': 'The narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm.', 'interventionNames': ['Device: Narrow band imaging bronchoscopy guided endobronchial biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White light bronchoscopy', 'description': 'The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm.', 'interventionNames': ['Device: White light bronchscopy guided endobronchial biopsy']}], 'interventions': [{'name': 'Narrow band imaging bronchoscopy guided endobronchial biopsy', 'type': 'DEVICE', 'description': 'Examination of the airways will be performed with the narrow band imaging mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.', 'armGroupLabels': ['Narrow band imaging bronchoscopy']}, {'name': 'White light bronchscopy guided endobronchial biopsy', 'type': 'DEVICE', 'description': 'Examination of the airways will be performed with the white light bronchoscopy mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.', 'armGroupLabels': ['White light bronchoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Ashutosh N Aggarwal, MD, DM', 'role': 'STUDY_CHAIR', 'affiliation': 'PGIMER, Chandigarh, India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pulmonary Medicine', 'investigatorFullName': 'Sahajal Dhooria', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}