Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Device: Thin bronchoscope and VBN

• Registration Number: NCT03802812
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-02-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational arm	Thin bronchoscope and VBN	Perform bronchial washing using investigational methods. * virtual bronchoscopic navigation (VBN)-guided thin bronchoscope (4.0mm of outer diameter)

Primary Outcome Measures

Name	Time	Method
detection of M. tuberculosis and resistant-conferring mutations	2months after procedure	evaulation by sensitivity, specificity, PPV and NPV

Secondary Outcome Measures

Name	Time	Method
time to appropriate treatment and stain/culture conversion	6months after procedure	date of treatment initiation and stain/culture negative conversion

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of