经肺实质外周肺结节支气管镜活检术（Bronchoscopic transparenchymal nodule access，BTPNA）
Bronchoscopic transparenchymal nodule access (BTPNA)
The Archimedes system (Broncus Medical) is a novel navigation system that uses a transparenchymal approach and therefore is not dependent on airway access to a lesion. Based on the pre-procedural CT scan, planning for the procedure is undertaken in proprietary software where the physician selects one of two computer selected points to exit the airway and begin the transparenchymal navigation. The exit point can be adjusted per physician preference and the vasculature is highlighted with a “virtual Doppler” function to help avoid vessels at the exit point. The airway is then punctured and dilated after which a steerable catheter is placed into the lung parenchyma. Utilizing the aforementioned fused fluoroscopic (augmented fluoroscopy) image the physician directs the catheter directly to the lesion for biopsy. Infrared cameras on the system detect the c-arm position and the optimal positioning of the c-arm is displayed.
Data from the first human trial with this novel system was published by Herth et al. in 2015 (9). While 12 patients were enrolled, the procedure was only possible in 10 of these patients (85% success rate). Of these ten patients, all had successful transparenchymal access, biopsy and diagnosis, confirmed by surgical resection. The average lesion size was 25 mm and the two unsuccessful procedures involved inaccessible lesions that were located in the left upper lobe. There were no adverse events, including pneumothorax and bronchopulmonary hemorrhage. A second study in humans with the BTPNA system involved six patients, of which 5 were able to have the procedure completed (10). The average lesion size was 19.8 mm and the procedure yielded a malignant diagnosis in all five cases. Pneumothorax was reported in 2 of the 5 patients (40%), 1 of which required a chest tube. Only one patient in both studies was able to have a successful transparenchymal biopsy of a lesion in the left upper lobe. There is currently a multi-site, multi-national study (EAST2) enrolling patients for further study. There are six U.S. sites, 1 in Germany and 3 in China. Estimated study completion date is early 2019.
Bronchoscopic transparenchymal nodule access (BTPNA).pdf
Introduction The promise of benefits from lung cancer screening is tempered by the false positive rate and the need to perform diagnostic procedures to determine the aetiology of the solitary pulmonary nodules (SPN) identified. We have developed a novel procedure which allows sampling of SPNs via a transparenchymal approach, and report the results from this as a first in human trial.
Methods This study was a prospective single-arm interventional study. We recruited patients with a SPN detected on CT imaging, which was suspicious for lung cancer, who were suitable for surgical resection. Using the subject's CT, an optimal airway wall point of entry (POE), and an avascular path through lung tissue from the POE to the SPN was calculated. A tunnel tract was created from the POE to the nodule using a set of catheter-based tools under fused fluoroscopy guidance. The patients proceeded to surgical resection immediately after the biopsy. The participants were followed-up for 6 months after the procedure. The primary endpoint of the study was to evaluate the feasibility to access and biopsy the nodule.
Results Twelve patients were recruited, and a tunnel pathway created in 10 patients. There were no adverse events during the procedures. Adequate biopsies were obtained from 10 patients (83%), which correlated with the histological findings from the surgical resection. Inspection of the resected lobes did not raise any safety concerns and indicated appropriately tunnelled pathways to the nodule.
Conclusions This first in human study demonstrates that bronchoscopic transparenchymal access of SPNs is feasible.
