Sarcoidosis, Pulmonary
Conditions
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.
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)
Interventions
DEVICENarrow 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.
DEVICEWhite 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.
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The pathologist analyzing the biopsy specimen will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complications: Bleeding | 1 day | The incidence of bleeding after the endobronchial biopsy |
| Procedure duration | 1 day | Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy) |
Countries
India
Outcome results
None listed