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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Device: bronchial washing using a thin bronchoscope

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeongha Mok; Phone Number: 82-51-240-7889; Email: mokgamokga@gmail.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jeongha Mok, MD; Phone Number: 82512407889; Email: mokgamokga@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Thick scope + BAL; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Jeongha Mok, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: TBBR trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No