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

Last updated: February 5, 2024
Sponsor: Ilya Sivokozov
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Lung Disease

Hiv

Treatment

radial EBUS

Virtual bronchoscopy navigation

Clinical Study ID

NCT05739695
VBN-REBUS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheralpulmonary 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

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

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: radial EBUS
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Kurgan Regional Oncological Dispensary

    Kurgan,
    Russian Federation

    Active - Recruiting

  • Central TB Research Institute

    Moscow,
    Russian Federation

    Active - Recruiting

  • P. Hertsen Moscow Oncology Research Institute

    Moscow,
    Russian Federation

    Active - Recruiting

  • National Medical Research Centre for Oncology

    Rostov-on-Don,
    Russian Federation

    Active - Recruiting

  • Tomsk Regional Oncological Dispensary

    Tomsk,
    Russian Federation

    Active - Recruiting

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