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

Not Applicable

Recruiting

• Conditions: Lung Cancer; Tuberculosis; Pneumonia
• Interventions: Diagnostic Test: Virtual bronchoscopy navigation; Diagnostic Test: radial EBUS

• Registration Number: NCT05739695
• Lead Sponsor: Ilya Sivokozov

Brief 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.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs)
2. PPL size 5 - 40 mm
3. Actual chest CT scan (<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format
4. Age > 18 years
5. Signed Informed consent form
6. Willing and ability to undergone a navigational bronchoscopy

Exclusion Criteria

1. Unability to undergone navigation bronchoscopy for any reason
2. Any malignant disease during last 36 months
3. Known central endobronchial lesion of any cause
4. HIV-infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VBN+rEBUS	Virtual bronchoscopy navigation	Combination of VBN and radial EBUS
VBN+rEBUS	radial EBUS	Combination of VBN and radial EBUS
VBN	Virtual bronchoscopy navigation	Virtual bronchoscopy
rEBUS	radial EBUS	Radial EBUS as a gold standard

Primary Outcome Measures

Name	Time	Method
Diagnostic Efficacy of navigational bronchoscopy in each study arm	At the end of study enrollment	Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm

Secondary Outcome Measures

Name	Time	Method
Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis	At the end of study enrollment	Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately

Trial Locations

Locations (6)

P. Hertsen Moscow Oncology Research Institute; 🇷🇺 Moscow, Russian Federation

National Medical Research Centre for Oncology; 🇷🇺 Rostov-on-Don, Russian Federation

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine; 🇷🇺 Chelyabinsk, Russian Federation

Kurgan Regional Oncological Dispensary; 🇷🇺 Kurgan, Russian Federation

Central TB Research Institute; 🇷🇺 Moscow, Russian Federation

Tomsk Regional Oncological Dispensary; 🇷🇺 Tomsk, Russian Federation