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

NCT06159023 | Recruiting

• 1 other identifier: TBBR trial
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• TB detection rate

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

  within 2 weeks of bronchoscopy

Secondary Outcomes (4)

• Mycobacterium tuberculosis culture

  within 8 weeks of bronchoscopy

• AFB(acid-fast bacilli) smear

  within 2 weeks of bronchoscopy

• Adverse event

  within 2 weeks of bronchoscopy

• Time to treatment

  within 8 weeks of bronchoscopy

Study Arms (2)

Thick scope + BAL

NO INTERVENTION

In this arm, participants with suspected pulmonary TB will be received bronchoscopic procedure using thick (5.9mm diameter) conventional bronchoscope and bronchoalveolar lavage (BAL).

Thin scope + BW

EXPERIMENTAL

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

Interventions

bronchial washing using a thin bronchoscope DEVICE

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.

Thin scope + BW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jeongha Mok

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeongha Mok

CONTACT

82-51-240-7889; mokgamokga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: December 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)