An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis (NABS)

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 6 February 2023

Summary

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.

Description

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)

Details
Condition Sarcoidosis, Pulmonary
Treatment Narrow band imaging bronchoscopy guided endobronchial biopsy, White light bronchscopy guided endobronchial biopsy
Clinical Study IdentifierNCT05311150
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on6 February 2023

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