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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bronchoalveolar Lavage Using a Conventional Bronchoscope vs. Bronchial Washing Using a Thin Bronchoscope to Diagnose Pulmonary Tuberculosis: a Prospective Randomized Trial

Conditions
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Tuberculosis, Pulmonary

Intervention / Treatment
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* Device: bronchial washing using a thin bronchoscope


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Thick scope + BAL<br>In this arm, participants with suspected pulmonary TB will be received bronchoscopic procedure using thick (5.9mm diameter) conventional bronchoscope and bronchoalveolar lavage (BAL). | |
| Experimental: Thin scope + BW<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB detection rate | Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid | within 2 weeks of bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycobacterium tuberculosis culture | Positivity rate of Mycobacterium tuberculosis culture in BAL or BW fluid | within 8 weeks of bronchoscopy | 
| AFB(acid-fast bacilli) smear | Positivity rate of AFB smear in BAL or BW fluid | within 2 weeks of bronchoscopy | 
| Adverse event | Adverse event related/unrelated to bronchoscopy | within 2 weeks of bronchoscopy | 
| Time to treatment | Time to treatment (TB treatment commencing date - bronchoscopy date, day) in participants with confirmed TB | within 8 weeks of bronchoscopy |