Fangfang Xie, Chun Li, Dan Liu, Yuanlin Song, Jiayuan Sun
Background: Despite advances like electromagnetic navigation bronchoscopy (ENB), biopsy of small peripheral pulmonary nodules (PPNs) remains suboptimal. Shape-sensing robotic-assisted bronchoscopy (ssRAB) is a promising alternative, but prospective multicenter randomized data vs. ENB are limited. We hypothesized ssRAB would yield superior diagnostic yield (DY) over ENB for PPNs 8–30 mm.
Methods: This is a multicenter, open-label, superiority randomized controlled trial. Adults with PPNs (8–30 mm) at or beyond subsegmental bronchi were randomized 1:1 to ssRAB or ENB-guided biopsy, stratified by nodule size, CT bronchus sign, and location. Procedures were performed under general anesthesia with the guidance of radial endobronchial ultrasound and fluoroscopy. Primary endpoint was ATS/ACCP-defined DY. The study was powered to detect a 15% absolute superiority margin for ssRAB vs. ENB.
Results: A total of 264 patients were randomized, of whom 260 underwent procedure (128 ssRAB; 132 ENB). The ssRAB group demonstrated a significantly superior diagnostic yield compared to ENB (91.4% [95% CI: 85.3%–95.1%] vs. 65.2% [95% CI: 56.7%–72.7%]; absolute difference 26.3%, p<0.0001). Benefit persisted in challenging subgroups: nodules ≤20 mm (88.3% vs. 53.2%, p<0.0001), absent CT bronchus sign (86.5% vs. 50.0%, p<0.0001), and outer-third lesions (90.8% vs. 66.2%, p=0.0006). Safety profiles were comparable between groups.
Conclusions: This first prospective multicenter randomized trial shows ssRAB significantly improves DY over ENB for PPN biopsy, especially in technically challenging cases. These findings support ssRAB as a more effective approach and may facilitate early lung cancer diagnosis.