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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
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.
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. Primary outcome:the diagnostic yield of EBB (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis) Secondary outcomes: 1. Complications related to the procedure (bleeding) 2. Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Postgraduate Institute of Medical Education and Research
Chandigarh, India
Start Date
January 1, 2022
Primary Completion Date
January 31, 2023
Completion Date
February 15, 2023
Last Updated
March 29, 2023
150
ACTUAL participants
Narrow band imaging bronchoscopy guided endobronchial biopsy
DEVICE
White light bronchscopy guided endobronchial biopsy
DEVICE
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
NCT05374447
NCT05291468
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05910554