Clinical trial NCT05311150: An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis, Pulmonary
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis
timeFrame: 7 days
Secondary outcomes:
measure: Complications: Bleeding
timeFrame: 1 day
measure: Procedure duration
timeFrame: 1 day
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: PGIMER, Chandigarh, India
name: Ashutosh N Aggarwal, MD, DM
role: STUDY_CHAIR
References: