Benign or malignant pulmonary lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) A 3-cm or smaller peripheral pulmonary lesion is present on chest CT and bronchoscopic examination is necessary to diagnose it or decide on a treatment strategy. 2) The bronchus or pulmonary artery involved in the lesion can be confirmed on chest CT. 3) Age of 20 years old or older 4) SpO2 of 90% or higher 5) Obtainment of written consent to participation in the study directly from the patients.
Exclusion criteria
Exclusion criteria: 1) A lesion is considered present on the central side of the subsegmental bronchus on bronchoscopy. 2) It is clear that the lesion is benign on imaging such as CT. 3) The presence of serious complication which may interfere with examination 4) Oral medication with anticoagulant and antiplatelet agent unable to be discontinued 5) Pregnancy 6) The presence of another complication which may seriously interfere with execution of the examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reaching the lesion and rate of cases for which cone beam CT was effective | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DirectPath Regions and the bronchial generation order for which virtual images are automatically prepared Regions and the bronchial generation order for which manual imaging is added 2. Bronchoscopy Consistency with virtual images Region and the bronchial generation order allowing insertion Region and the bronchial generation order observed 3. EBUS Findings: within, adjacent to, invisible 4. Cone beam CT Findings: centered, inside, and outside Number of acquisitions 5. Diagnostic yield Diagnostic yield (histological diagnostic yield and overall diagnostic yield combining culture, cytology, and histological diagnosis) Diagnostic yield by the final diagnosis (benign, malignant) Diagnostic yield by the lesion size (larger or smaller than 2 cm) Diagnostic yield by the distance of the lesion from the pulmonary hilum (1/3 intermediate, 1/3 lateral) Diagnostic yield by the pulmonary lobe Diagnostic yield by the presence or absence of involved bronchus Diagnostic yield by the character of the lesion (solid, ground glass nodule) Diagnostic yield by cone beam CT findings 6. Examination and fluoroscopy time and X-ray exposure Bronchoscopic examination time Total fluoroscopy time Cumulative dose area product (DAP) (fluoroscopy, acquisition) Cumulative Frontal Air Kerma 7. Safety Complications | — |
Countries
Japan
Contacts
Gifu Prefectural General Medical Center Department of Pulmonary Medicine