The match 2 study: Robotic assisted bronchoscopy with integrated imaging with assessment of digital tomosynthesis...

Robotic-assisted bronchoscopy (RAB) with embedded digital tomosynthesis (DT) provides real-time, intraoperative nodule localization. This study examines the performance of RAB with embedded DT and integrated AF to achieve tool-in-lesion (TIL) confirmation via cone beam computer tomography (CBCT).

This was a prospective, bicentric, single-arm, non-randomized observational trial. Thirty-one patients with peripheral pulmonary nodules underwent RAB with embedded DT. Navigation was guided by DT and augmented fluoroscopy (AF). Primary endpoints were successful navigation to target lesions and successful TIL as confirmed by CBCT. Secondary endpoints included diagnostic yield based on the strict Delphi consensus definition of diagnostic yield along with serious device or procedure-related adverse events.

Thirty-one patients were enrolled across two sites. Thirty-one lung nodules were successfully biopsied. The mean lesion size measured by longest cross-sectional diameter was 16 mm (±6.7 mm). DT demonstrated TIL in 30 of 31 nodules (96.7 %), with one case resulting in tool-touching-lesion (TTL). Of the 30 nodules demonstrating TIL by DT, TIL was confirmed in 29 nodules by CBCT (concordance rate of 96.7 %). Overall TIL confirmed by CBCT was 29 of 31 nodules (93.5 %). A diagnosis was obtained in 30 of 31, resulting in a 96.7 % diagnostic yield by strict definition. Pneumothorax occurred in 1 of 31 cases (3 %).

RAB with embedded DT demonstrated a high rate of TIL confirmed by CBCT. The strong concordance between the DT with AF and CBCT demonstrates the reliability of DT and AF for real-time intraprocedural guidance.