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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Sarcoidosis, Pulmonary

Treatments: Device: White light bronchscopy guided endobronchial biopsy; Device: Narrow band imaging bronchoscopy guided endobronchial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05311150

INT/IEC/2021/SPL-1817

Details and patient eligibility

About

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.

Full 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)

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age more than 18 years.
2. 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.
3. Willing to give informed consent.

Exclusion criteria

1. Hemodynamic instability (systolic BP <100 mm Hg).
2. Pregnancy.
3. Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.
4. Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Narrow band imaging bronchoscopy

Active Comparator group

Description:

The narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm.

Treatment:

Device: Narrow band imaging bronchoscopy guided endobronchial biopsy

White light bronchoscopy

Active Comparator group

Description:

The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm.

Treatment:

Device: White light bronchscopy guided endobronchial biopsy