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NCT06159023 | RECRUITING | Tuberculosis, Pulmonary

Conventional Bronchoscope With BAL vs. Thin Bronchoscope With BW to Diagnose Pulmonary TB
Sponsor:

Pusan National University Hospital

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.

Condition or disease

Tuberculosis, Pulmonary

Intervention/treatment

bronchial washing using a thin bronchoscope

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 132 participants
Masking : SINGLE
Primary Purpose : DIAGNOSTIC
Official Title : Bronchoalveolar Lavage Using a Conventional Bronchoscope vs. Bronchial Washing Using a Thin Bronchoscope to Diagnose Pulmonary Tuberculosis: a Prospective Randomized Trial
Actual Study Start Date : 2023-12-15
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Conventional Bronchoscope With BAL vs. Thin Bronchoscope With BW to Diagnose Pulmonary TB

Location Details

NCT06159023

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Korea, Republic of,

Pusan National University Hospital

Busan, Korea, Republic of, 49241