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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05311150
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Postgraduate Institute of Medical Education and Research
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ashutosh N Aggarwal, MD, DM
Principal Investigator Affiliation	PGIMER, Chandigarh, India
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	India
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoidosis, Pulmonary

Additional Details

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)

Arms & Interventions

Arms

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.

Active Comparator: White light bronchoscopy

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

Interventions

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.

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.

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