Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
brief summary
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: 1. 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 2. 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.
detailed description
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).
official title
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)