デュアル補正ロボット気管支鏡システムと超薄型カテーテルによる困難な末梢肺結節の診断：多施設前向き試験

Conventional bronchoscopy has imited diagnostic yield for challenging peripheral pulmonary nodules(C-PPNs), particularly for small (≤20 mm), pleural-contact, or reverse-angle (bifurcation angle ≤90°) nodules. This prospective multi-centre study evaluates the novel robotic bronchoscopy system (RBS) with ultra-thin catheters in C-PPNs under radiation-free conditions.

This multi-centre, prospective study enrolled 89 patients with C-PPN (characterised by a diameter ≤20 mm, pleural-contact, or an angle ≤90°) from three centres, who underwent RBS biopsy between 2022 and 2024. Diagnostic yield were conducted based on specific nodule characteristics. Univariate and multivariate logistic regressions were performed to evaluate the association between nodular-related factors and diagnostic yield.

The average nodule size was 19.54 mm (53.9%, ≤20 mm). Pleural-contact was observed in 71.9% of nodules, and 64.0% exhibited a reverse-angle (≤90°). The novel system achieved 100% navigation and sampling success. Importantly, the diagnostic yield reached 84.2%, with 88.3% sensitivity for malignancy. Diagnostic performance were comparable across Single-criteria, Dual-criteria, and Triple-criteria groups (p = 0.416). Nodules ≤20 mm had lower yield (75.0%) compared to pleura-contact (90.6%, p = 0.013) or reverse-angle (89.5%, p = 0.028). Logistic regression confirmed nodule size >20 mm as a significant diagnostic yield predictor. Notably, no pneumothorax occurred, and only two patients experienced minor bleeding.

This prospective multi-centre study introduced the concept of C-PPN, establishing a valuable reference for subsequent research. Moreover, the novel system featuring ultra-thin catheters demonstrated superior performance, achieving 100% navigation success, 84.2% diagnostic yield and 0 pneumothorax, in such nodules without radiation guidance.