NCT03802812
Completed
Not Applicable
Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
ConditionsTuberculosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- Pusan National University Hospital
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- detection of M. tuberculosis and resistant-conferring mutations
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jeongha Mok
Clinical Professor
Pusan National University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
detection of M. tuberculosis and resistant-conferring mutations
Time Frame: 2months after procedure
evaulation by sensitivity, specificity, PPV and NPV
Secondary Outcomes
- time to appropriate treatment and stain/culture conversion(6months after procedure)
Study Sites (1)
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