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Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Recruiting
18 years and older
All
Phase N/A
Endpoints Primary

To evaluate diagnostic yield

Secondary
  • To evaluate rate of pneumothorax.
  • To evaluate rate of pneumothorax requiring chest tube placement.
  • To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
  • To evaluate need for hospitalization after procedure.
  • To evaluate duration of the procedure.
  • To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
  • To evaluate need for additional nodule biopsy.
  • To evaluate need for additional procedure for staging.
  • To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
  • To evaluate need for F-Nav during navigation bronchoscopy.
  • To evaluate bronchoscopy yield defined as the combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.
Study details
    Lung Nodule

NCT04250194

Vanderbilt-Ingram Cancer Center

19 February 2024

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