Tuberculosis, Pulmonary
Conditions
Brief summary
This study aims to compare the diagnostic yield of bronchoalveolar lavage (BAL) using a thick conventional bronchoscope and bronchial washing (BW) using a thin bronchoscope in the diagnosis of pulmonary tuberculosis.
Detailed description
In patients with suspected pulmonary tuberculosis (TB), confirm the presence of TB bacilli through sputum testing is essential for diagnosis. However, the sensitivity of sputum specimens is suboptimal, and some patients may be unable to produce sputum. In such situations, it is traditionally known that obtaining samples through bronchoscopy increases the diagnostic yield of pulmonary TB. Typically, the method of using a thick, conventional bronchoscope to perform bronchial washing (BW) or bronchoalveolar lavage (BAL) is commonly employed. However, a drawback of the conventional bronchoscope is its inability to reach close to peripheral pulmonary TB lesions due to its larger diameter. Recent studies have reported an increased diagnostic yield for pulmonary TB when using a thin bronchoscope for BW compared to using a thick, conventional bronchoscope for BW. However, a direct comparison with the method of performing BAL (BAL may have a higher diagnostic yield compared to BW) using a conventional bronchoscope has not been conducted. This study aims to prospectively compare the diagnostic yield for pulmonary TB between BAL using a conventional bronchoscope and BW using a thin bronchoscope.
Interventions
DEVICEbronchial washing using a thin bronchoscope
For intervention, we plan to perform bronchial washing using a thin bronchoscope instead of bronchoalveolar lavage with the conventional thick bronchoscope to diagnose pulmonary TB.
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* participants age \> 17 years with suspected pulmonary TB * possible active pulmonary TB evident on chest radiography or CT scan * negative AFB smear results (using two consecutive self-expectorated sputum) * negative TB-PCR results (using one self-expectorated sputum) * inability to produce self-expectorated sputum
Exclusion criteria
* a request for empirical TB treatment rather than bronchoscopy * suspect pulmonary TB lesions that are difficult to target for BAL or BW (e.g., multiple discrete tiny nodules) * contra-indication of bronchoscopy (e.g., bleeding tendency, hypoxemia requiring oxygen, or uncontrolled cardio/cerebrovascular disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB detection rate | within 2 weeks of bronchoscopy | Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycobacterium tuberculosis culture | within 8 weeks of bronchoscopy | Positivity rate of Mycobacterium tuberculosis culture in BAL or BW fluid |
| AFB(acid-fast bacilli) smear | within 2 weeks of bronchoscopy | Positivity rate of AFB smear in BAL or BW fluid |
| Adverse event | within 2 weeks of bronchoscopy | Adverse event related/unrelated to bronchoscopy |
| Time to treatment | within 8 weeks of bronchoscopy | Time to treatment (TB treatment commencing date - bronchoscopy date, day) in participants with confirmed TB |
Countries
South Korea
Contacts
Primary ContactJeongha Mok
Outcome results
None listed