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

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159023
• Other study ID #: TBBR trial
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

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