Tuberculosis
Conditions
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.
Interventions
DEVICEThin bronchoscope and VBN
targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| detection of M. tuberculosis and resistant-conferring mutations | 2months after procedure | evaulation by sensitivity, specificity, PPV and NPV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to appropriate treatment and stain/culture conversion | 6months after procedure | date of treatment initiation and stain/culture negative conversion |
Countries
South Korea
Outcome results
None listed