NCT05311150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 26, 2022

Last Update Submit

March 28, 2023

Conditions

Sarcoidosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Complications: Bleeding

    1 day

  • Procedure duration

    1 day

Study Arms (2)

Narrow band imaging bronchoscopy

ACTIVE COMPARATOR

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

White light bronchoscopy

ACTIVE COMPARATOR

The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm.

Device: White light bronchscopy guided endobronchial biopsy

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.

Narrow band imaging bronchoscopy
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.

White light bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years.
  • 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.
  • Willing to give informed consent.

You may not qualify if:

  • Hemodynamic instability (systolic BP \<100 mm Hg).
  • Pregnancy.
  • Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.
  • Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

  • Rathi K, Dogra P, Agarwal R, Singh Sehgal I, Muthu V, Thurai Prasad K, Aggarwal AN, Bal A, Gupta N, Dhooria S. A randomized trial of narrow band imaging for performing airway mucosal biopsy in pulmonary sarcoidosis (NABS). Sarcoidosis Vasc Diffuse Lung Dis. 2025 Sep 30;42(3):16418. doi: 10.36141/svdld.v42i3.16418.

    PMID: 41026031DERIVED

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Ashutosh N Aggarwal, MD, DM

    PGIMER, Chandigarh, India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The pathologist analyzing the biopsy specimen will be masked.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pulmonary Medicine

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 5, 2022

Study Start

January 1, 2022

Primary Completion

January 31, 2023

Study Completion

February 15, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)