NCT05739695

A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions

Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ilya Sivokozov · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Peripheral pulmonary lesions are of growing importance in respiratory field. Early detection of lung cancer, tuberculosis and other diseases often needs a bronchoscopic investigation with different types of navigation. Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS) and combination of both techniques.

Detailed description

Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy, radial EBUS and combination of both techniques. Around 300 patients with incidentally detected peripheral pulmonary lesions will be enrolled in 9 centers among Russia. All patients after obtaining an informed consent will be randomized in 1:1:1 fashion to three study groups depending on type of navigation technique used. All patients will undergone navigational bronchoscopy with rEBUS (group A), VBN (group B) and rEBUS+VBN (group C), data on diagnostic efficacy and safety of each modality of navigation will be analyzed.

Conditions

• Lung Cancer
• Tuberculosis
• Pneumonia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Virtual bronchoscopy navigation	It is planned to use VBN as the only navigation technique to compare it with rEBUS
DIAGNOSTIC_TEST	radial EBUS	It is planned to use rEBUS as the only navigation technique to compare it with VBN

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2023-02-22
• Last updated: 2024-02-06

Locations

6 sites across 1 country: Russia