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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159023
Other study ID # TBBR trial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Pusan National University Hospital
Contact Jeongha Mok
Phone 82-51-240-7889
Email mokgamokga@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Pusan National University Hospital Busan

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary TB detection rate Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid within 2 weeks of bronchoscopy
Secondary Mycobacterium tuberculosis culture Positivity rate of Mycobacterium tuberculosis culture in BAL or BW fluid within 8 weeks of bronchoscopy
Secondary AFB(acid-fast bacilli) smear Positivity rate of AFB smear in BAL or BW fluid within 2 weeks of bronchoscopy
Secondary Adverse event Adverse event related/unrelated to bronchoscopy within 2 weeks of bronchoscopy
Secondary Time to treatment Time to treatment (TB treatment commencing date - bronchoscopy date, day) in participants with confirmed TB within 8 weeks of bronchoscopy
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