Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy
- Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 70%, using a validated clinical prediction model, which is either:
- The Brock model14 if no PET scan data are available, or
- The Herder model15 if PET-CT data are available.
- Size between 10 and 30 mm (long diameter).
- Location peripheral, here defined as occupying the middle or outer third lung zones.
- Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.
Exclusion Criteria:
- Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
- Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).