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

Not Applicable

Completed

• Conditions: Sarcoidosis, Pulmonary
• Interventions: Device: Narrow band imaging bronchoscopy guided endobronchial biopsy; Device: White light bronchscopy guided endobronchial biopsy

• Registration Number: NCT05311150
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-03-26
• Study First Posted: 2022-04-05
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narrow band imaging bronchoscopy	Narrow band imaging bronchoscopy guided endobronchial biopsy	The narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm.
White light bronchoscopy	White light bronchscopy guided endobronchial biopsy	The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm.

Primary Outcome Measures

Name	Time	Method
Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis	7 days	Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)

Secondary Outcome Measures

Name	Time	Method
Procedure duration	1 day	Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
Complications: Bleeding	1 day	The incidence of bleeding after the endobronchial biopsy

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India