Diagnosis of Sub-centimeter Nodules Through Shape-sensing Robotic Assisted Bronchoscopy: Real-world Outcomes From the Ion Registry

Document Type

Conference Proceeding

Publication Date

5-20-2025

Publication Title

Am J Respir Crit Care Med

Abstract

RATIONALE: As technology for biopsy of peripheral pulmonary nodules advances, the size of suspicious nodules referred for biopsy has decreased. This can be partly attributed to tools such as shape-sensing robotic-assisted bronchoscopy (ssRAB), which can increase the likelihood of a diagnostic result. Literature describing the biopsy of sub-centimeter nodules is primarily single center with a reported diagnostic yield for robotic bronchoscopy of 67%1, and 71%2 for CT-guided percutaneous biopsy; robust prospective multi-center data is needed to further understand the feasibility and clinical value of <1cm nodule biopsies. Herein, we report data from the prospective Ion Registry describing outcomes for patients with sub-centimeter nodules biopsied using ssRAB. METHODS: Patients with at least one (1) nodule <1cm that underwent ssRAB biopsy were identified from those enrolled in the Ion Registry. Subjects with multiple lesions were included if all nodules were <1cm in largest diameter. Nodule and procedure characteristics are reported with descriptive statistics; diagnostic yield was assessed using the ATS/ACCP recommended guidelines of index biopsy results only. Safety was assessed as the rate of pneumothorax requiring intervention and Nashville Grade ≥3 bleeding. RESULTS: Fifty-four (54) subjects and 57 sub-centimeter nodules were identified across 9 centers and 15 investigators; procedures were completed October 2023 through September 2024. The majority of nodules (47.4%) were incidental findings. Median nodule diameter was 8 mm (IQR: 7,9; range: 4.0-9.7 mm) with 66.7% of nodules located in the outer-third of the lung, and predominantly (57.9%) in the upper lobes. CT bronchus sign was present in 24.6% of nodules, and most (89.5%) nodule were solid. Median procedure time was 34.5 mins (IQR: 26,47; range: 9-89 mins); fixed or mobile CBCT was utilized for 80.7% (46/57) of nodules. The flexision biopsy needle and cryoprobe were used in 91% and 49% of biopsies, respectively. Diagnostic yield was 83% (45/54) using index biopsy results, 59% of which were malignant. No (0%) pneumothorax requiring intervention, Nashville Grade ≥3 bleeding events. CONCLUSION: Preliminary results from this prospective, multi-center registry cohort demonstrate peripheral nodules <1cm can be safely and effectively diagnosed through ssRAB biopsy and highlight the impact of ssRAB in enhancing lung nodule diagnosis, particularly when combined with CBCT. These findings suggest ssRAB may be considered a viable option for the biopsy of suspicious sub-centimeter nodules, further optimizing the management of patients with suspected lung cancer.

Volume

211

First Page

A2720

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