An interventional study of bronchial washing using a thin bronchoscope in Tuberculosis, Pulmonary, sponsored by Pusan National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Pusan National University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 132 is close to the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, participants with suspected pulmonary TB will be received bronchoscopic procedure using thick (5.9mm diameter) conventional bronchoscope and bronchoalveolar lavage (BAL).
In this arm, participants with suspected pulmonary TB will be received bronchoscopic procedure using thin (4.0mm diameter) bronchoscope and bronchial washing (BW).
Device: bronchial 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.
TB detection rate
Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid
Time frame: within 2 weeks of bronchoscopy
Mycobacterium tuberculosis culture
Positivity rate of Mycobacterium tuberculosis culture in BAL or BW fluid
Time frame: within 8 weeks of bronchoscopy
AFB(acid-fast bacilli) smear
Positivity rate of AFB smear in BAL or BW fluid
Time frame: within 2 weeks of bronchoscopy
Adverse event
Adverse event related/unrelated to bronchoscopy
Time frame: within 2 weeks of bronchoscopy
Time to treatment
Time to treatment (TB treatment commencing date - bronchoscopy date, day) in participants with confirmed TB
Time frame: within 8 weeks of bronchoscopy
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.
Of 42 non-industry interventional studies with no phase under Tuberculosis, Pulmonary, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 12 months is below that.
Counting every sponsor, half of 42 studies reached it within 17 months; a quarter within 11 and three quarters within 29.
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Pusan National University Hospital