Lung Cancer, Pneumonia, Tuberculosis
Conditions
Keywords
navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB
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.
Interventions
DIAGNOSTIC_TESTVirtual bronchoscopy navigation
It is planned to use VBN as the only navigation technique to compare it with rEBUS
DIAGNOSTIC_TESTradial EBUS
It is planned to use rEBUS as the only navigation technique to compare it with VBN
Sponsors
Ilya Sivokozov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of each study arm | At the end of study enrollment | Incidence of complications reported at each study arm procedures |
Countries
Russia
Contacts
Primary ContactIlya Sivokozov, MD PhD
Outcome results
None listed