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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis
研究概览
简要总结
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.
详细描述
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:
- Complications related to the procedure (bleeding)
- Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The pathologist analyzing the biopsy specimen will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Hemodynamic instability (systolic BP <100 mm Hg).
- •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.
结局指标
主要结局
Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis
时间窗: 7 days
Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)
次要结局
- Procedure duration(1 day)
- Complications: Bleeding(1 day)
研究者
Sahajal Dhooria
Associate Professor of Pulmonary Medicine
Post Graduate Institute of Medical Education and Research, Chandigarh