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

Not Applicable

Recruiting

• Conditions: Tuberculosis, Pulmonary
• Interventions: Device: bronchial washing using a thin bronchoscope

• Registration Number: NCT06159023
• Lead 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.

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Study Start: 2023-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thin scope + BW	bronchial washing using a thin bronchoscope	In this arm, participants with suspected pulmonary TB will be received bronchoscopic procedure using thin (4.0mm diameter) bronchoscope and bronchial washing (BW).

Primary Outcome Measures

Name	Time	Method
TB detection rate	within 2 weeks of bronchoscopy	Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of