This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
- a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
- navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
Endpoints:
Primary:
• To evaluate diagnostic accuracy through 12 months of clinical follow-up
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 (digital tomosynthesis) during navigation bronchoscopy.
- To evaluate diagnostic yield
- To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).
