Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- detection of M. tuberculosis and resistant-conferring mutations
研究概览
简要总结
This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and stain/culture conversion are also evaluated.
详细描述
Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided thin bronchoscope.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 18 or more
- •persons who are suspected with pulmonary tuberculosis on radiologic examination
- •persons who cannot spit sputum or persons with negative results on sputum AFB smear and TB-PCR or Xpert MTB/RIF assay
排除标准
- •persons who do not agree with bronchoscopy (persons who want empirical treatment for TB)
- •persons with contraindications for bronchoscopy
- •bleeding tendency
- •uncontrolled respiratory disease (hypoxemia)
- •uncontrolled cardiovascular disease
研究组 & 干预措施
Conventional arm
Perform bronchial washing using conventional methods.
- CT-guided thick bronchoscope
Investigational arm
Perform bronchial washing using investigational methods.
- virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)
干预措施: Thin bronchoscope and VBN (Device)
结局指标
主要结局
detection of M. tuberculosis and resistant-conferring mutations
时间窗: 2months after procedure
evaulation by sensitivity, specificity, PPV and NPV
次要结局
- time to appropriate treatment and stain/culture conversion(6months after procedure)
研究者
Jeongha Mok
Clinical Professor
Pusan National University Hospital