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

Ilya Sivokozov

Status: Enrolling

Conditions: Tuberculosis; Lung Cancer; Pneumonia

Treatments: Diagnostic Test: radial EBUS; Diagnostic Test: Virtual bronchoscopy navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05739695

VBN-REBUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

VBN

Experimental group

Description:

Virtual bronchoscopy

Treatment:

Diagnostic Test: Virtual bronchoscopy navigation

VBN+rEBUS

Experimental group

Description:

Combination of VBN and radial EBUS

Treatment:

Diagnostic Test: radial EBUS

Diagnostic Test: Virtual bronchoscopy navigation

rEBUS

Active Comparator group

Description:

Radial EBUS as a gold standard

Treatment:

Diagnostic Test: radial EBUS