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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBN | Experimental | Virtual bronchoscopy |
|
| VBN+rEBUS | Experimental | Combination of VBN and radial EBUS |
|
| rEBUS | Active Comparator | Radial EBUS as a gold standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual bronchoscopy navigation | Diagnostic Test | It is planned to use VBN as the only navigation technique to compare it with rEBUS |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of each study arm | Incidence of complications reported at each study arm procedures | At the end of study enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilya Sivokozov, MD PhD | Contact | +79670457905 | sivokozov@bronchology.ru |
| Name | Affiliation | Role |
|---|---|---|
| Ilya Sivokozov, MD PhD | Central TB Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine | Recruiting | Chelyabinsk | Russia |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D014376 | Tuberculosis |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| radial EBUS | Diagnostic Test | It is planned to use rEBUS as the only navigation technique to compare it with VBN |
|
| Kurgan Regional Oncological Dispensary | Recruiting | Kurgan | Russia |
|
| Central TB Research Institute | Recruiting | Moscow | Russia |
|
| P. Hertsen Moscow Oncology Research Institute | Recruiting | Moscow | Russia |
|
| National Medical Research Centre for Oncology | Recruiting | Rostov-on-Don | Russia |
|
| Tomsk Regional Oncological Dispensary | Recruiting | Tomsk | Russia |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |