Randomized control trial of virtual bronchoscopic navigation system (VBN) guided bronchoscopy in diagnosis of peripheral pulmonary lesion (PPL)

Phase 2

• Conditions: 18- year- old or more patients indicated for bronchoscopy to evaluate pulmonary lesions seen on a CT scan.The target lesion is 3 cm or smaller with CT bronchus sign.; Peripheral pulmonary lesion; Bronchoscopy

• Registration Number: TCTR20200807003
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-07
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

18-year-old or more patients indicated for bronchoscopy to evaluate pulmonary lesions seen on a CT scan. The target lesion is 3 cm or smaller with CT bronchus sign.

Exclusion Criteria

Pregnancy
Patients who have endobronchial lesion
Patients with contraindication for bronchoscopy: hemodynamic collapse, profound refractory hypoxemia, malignant arrhythmia, bleeding diathesis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to achieve target lesion Bronchoscope is introduced through the nose until achieving target lesion Stopwatch timer

Secondary Outcome Measures

Name	Time	Method
Procedural duration Bronchoscope is introduced through the nose until the procedure is finished Stopwatch timer,Diagnostic yield of VBN 2 weeks post procedure Definite diagnosis on histopathologic finding,Visualization yield of target lesion using R-EBUS Before specimen collection Endobronchial ultrasound imaging,Size of target lesion 1 day before the procedure Software tools,Characteristics of target lesion 1 day before the procedure Software tools,Location of target lesion 1 day before the procedure Software tools