Clinical trial NCT05739695: A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions
Official title: Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Tuberculosis
Pneumonia
Keywords: navigation bronchoscopy
virtual bronchoscopy navigation
radial endobronchial ultrasound
BAL
TBLB
Lead sponsor: Central TB Research Institute
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Efficacy of navigational bronchoscopy in each study arm
timeFrame: At the end of study enrollment
Secondary outcomes:
measure: Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis
timeFrame: At the end of study enrollment
Other outcomes:
measure: Safety profile of each study arm
timeFrame: At the end of study enrollment
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
city: Kurgan
country: Russian Federation
facility: Kurgan Regional Oncological Dispensary
city: Moscow
country: Russian Federation
facility: Central TB Research Institute
city: Moscow
country: Russian Federation
facility: P. Hertsen Moscow Oncology Research Institute
city: Rostov-on-Don
country: Russian Federation
facility: National Medical Research Centre for Oncology
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Oncological Dispensary
Study officials:
affiliation: Central TB Research Institute
name: Ilya Sivokozov, MD PhD
role: STUDY_CHAIR
References: