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

Ilya Sivokozov300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Lung Cancer Tuberculosis Pneumonia

Interventions

Virtual bronchoscopy navigationDIAGNOSTIC_TEST

It is planned to use VBN as the only navigation technique to compare it with rEBUS

radial EBUSDIAGNOSTIC_TEST

It is planned to use rEBUS as the only navigation technique to compare it with VBN

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, Russia

RECRUITING

Kurgan Regional Oncological Dispensary

Kurgan, Russia

RECRUITING

Central TB Research Institute

Moscow, Russia

Outcomes

Primary Outcomes

Diagnostic Efficacy of navigational bronchoscopy in each study arm

Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm

Time frame: At the end of study enrollment

Secondary Outcomes

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

Time frame: At the end of study enrollment

Central Contacts

Ilya Sivokozov, MD PhD

CONTACT

+79670457905 sivokozov@bronchology.ru

Data from ClinicalTrials.gov

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