Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

Pusan National University

Status: Completed

Conditions: Tuberculosis

Treatments: Device: Thin bronchoscope and VBN

Study type: Interventional

Funder types: Other

Identifiers

NCT03802812

2018R1C1B5085364 (Other Grant/Funding Number)

TBVBN study

Details and patient eligibility

About

This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and stain/culture conversion are also evaluated.

Full description

Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided thin bronchoscope.

Enrollment: 88 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age of 18 or more
• persons who are suspected with pulmonary tuberculosis on radiologic examination
• persons who cannot spit sputum or persons with negative results on sputum AFB smear and TB-PCR or Xpert MTB/RIF assay

Exclusion criteria

• persons who do not agree with bronchoscopy (persons who want empirical treatment for TB)

• persons with contraindications for bronchoscopy

  • bleeding tendency
  • uncontrolled respiratory disease (hypoxemia)
  • uncontrolled cardiovascular disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Conventional arm

No Intervention group

Description:

Perform bronchial washing using conventional methods. * CT-guided thick bronchoscope

Investigational arm

Active Comparator group

Description:

Perform bronchial washing using investigational methods. * virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)

Treatment:

Device: Thin bronchoscope and VBN