A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Diagnostic yield of peripheral airway biopsy for the detection of granulomas
研究概览
简要总结
Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an increased diagnostic yield for the detection of granulomas.
详细描述
Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that is more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. Endobronchial biopsy (EBB), taken from the central airways with standard-sized videobronchoscopes, has long been used in clinical practice, although its diagnostic yield has been shown to be widely variable across different ethnicities. A recent prospective study shows that the diagnostic yield of EBB in a sarcoidosis population with large prevalence of white Europeans is 37% overall, and 22% in patients who do not have endobronchial abnormalities. The diagnostic yield of biopsies taken from peripheral airways with ultrathin bronchoscopes was never been evaluated, to our knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
- •Age >18 years
- •American Society of Anesthesiologists score 1-3.
排除标准
- •Inability of unwillingness to consent
- •Steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy.
- •Pregnancy.
- •Uncontrolled coagulopathy
- •Contraindication to the temporary interruption of anticoagulants or antiplatelet drugs, except aspirin.
结局指标
主要结局
Diagnostic yield of peripheral airway biopsy for the detection of granulomas
时间窗: 1 month
The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of peripheral airway biopsy shows non necrotizing granulomas/all the patients submitted to the sampling procedure).
次要结局
- Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy(6 months)
- Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage(6 months)
- Diagnostic yield for the detection of endobronchial granulomas according to sex(6 months)
- Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity(6 months)
- Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities(6 months)
- Complication rate(1 day)