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Clinical Trials/NCT06159023
NCT06159023
Recruiting
Not Applicable

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

Pusan National University Hospital1 site in 1 country132 target enrollmentDecember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tuberculosis, Pulmonary
Sponsor
Pusan National University Hospital
Enrollment
132
Locations
1
Primary Endpoint
TB detection rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

TB detection rate

Time Frame: within 2 weeks of bronchoscopy

Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid

Secondary Outcomes

  • Mycobacterium tuberculosis culture(within 8 weeks of bronchoscopy)
  • Adverse event(within 2 weeks of bronchoscopy)
  • AFB(acid-fast bacilli) smear(within 2 weeks of bronchoscopy)
  • Time to treatment(within 8 weeks of bronchoscopy)

Study Sites (1)

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