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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Tuberculosis, Pneumonia

Intervention / Treatment
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* Diagnostic Test: Virtual bronchoscopy navigation
* Diagnostic Test: radial EBUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs) PPL size 5 - 40 mm Actual chest CT scan (<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format Age > 18 years Signed Informed consent form Willing and ability to undergone a navigational bronchoscopy Exclusion Criteria: Unability to undergone navigation bronchoscopy for any reason Any malignant disease during last 36 months Known central endobronchial lesion of any cause HIV-infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VBN<br>Virtual bronchoscopy | Diagnostic Test: Virtual bronchoscopy navigation<br>* It is planned to use VBN as the only navigation technique to compare it with rEBUS<br>|
| Experimental: VBN+rEBUS<br>Combination of VBN and radial EBUS | Diagnostic Test: Virtual bronchoscopy navigation<br>* It is planned to use VBN as the only navigation technique to compare it with rEBUS<br>Diagnostic Test: radial EBUS<br>* It is planned to use rEBUS as the only navigation technique to compare it with VBN<br>|
| Active Comparator: rEBUS<br>Radial EBUS as a gold standard | Diagnostic Test: radial EBUS<br>* It is planned to use rEBUS as the only navigation technique to compare it with VBN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Efficacy of navigational bronchoscopy in each study arm | Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm | At the end of study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis | Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately | At the end of study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BAL, navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, TBLB