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

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

Recruiting
18 years and older
All
Phase N/A

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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.

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

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

Study details
    Lung Cancer
    Tuberculosis
    Pneumonia

NCT05739695

Ilya Sivokozov

18 February 2024

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