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

Post Graduate Institute of Medical Education and Research, Chandigarh150 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Sarcoidosis, Pulmonary

Interventions

Narrow band imaging bronchoscopy guided endobronchial biopsyDEVICE

Examination of the airways will be performed with the narrow band imaging mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.

White light bronchscopy guided endobronchial biopsyDEVICE

Examination of the airways will be performed with the white light bronchoscopy mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Outcomes

Primary Outcomes

Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis

Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)

Time frame: 7 days

Secondary Outcomes

Complications: Bleeding

The incidence of bleeding after the endobronchial biopsy

Time frame: 1 day

Procedure duration

Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)

Time frame: 1 day

Data from ClinicalTrials.gov

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