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

• Sponsor: Postgraduate Institute of Medical Education and Research (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05311150
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis, Pulmonary	Device: Narrow band imaging bronchoscopy guided endobronchial biopsy; Device: White light bronchscopy guided endobronchial biopsy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The pathologist analyzing the biopsy specimen will be masked.
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Narrow band imaging bronchoscopy The narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm.	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.
Active Comparator: White light bronchoscopy The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Complications: Bleeding [1 day]

   The incidence of bleeding after the endobronchial biopsy

2. Procedure duration [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Postgraduate Institute of Medical Education and Research	Chandigarh		India	160012

Sponsors and Collaborators

• Postgraduate Institute of Medical Education and Research

Investigators

• Study Chair: Ashutosh N Aggarwal, MD, DM, PGIMER, Chandigarh, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sahajal Dhooria, Associate Professor of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research
• ClinicalTrials.gov Identifier: NCT05311150
• Other Study ID Numbers: INT/IEC/2021/SPL-1817
• First Posted: Apr 5, 2022
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis

Study Results

No Results Posted as of Apr 13, 2022