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

Sarcoidosis, Pulmonary Clinical Trial

— NABS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311150
• Other study ID #: INT/IEC/2021/SPL-1817
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 15, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Device:
• Narrow band imaging bronchoscopy guided endobronchial biopsy
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 biopsy
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.

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	7 days
Secondary	Complications: Bleeding	The incidence of bleeding after the endobronchial biopsy	1 day
Secondary	Procedure duration	Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)	1 day