Robotic-Assisted Bronchoscopy with Integrated Cone-Beam CT vs. Conventional Bronchoscopy for Diagnosing Peripheral Pulmonary Lesions: An Open-Label Randomized Controlled Trial

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Background: Robotic-assisted bronchoscopy (RAB) with integrated cone-beam computed tomography (CBCT) represents a cutting-edge approach for diagnosing hard-to-access peripheral pulmonary lesions (PPLs). Despite its potential, direct comparisons with conventional bronchoscopy (CB) are lacking. Methods: In this investigator-initiated, single-center, open-label randomized trial, patients with PPLs were randomized 1:1 to undergo either CB with ultra-thin bronchoscopes and 2D fluoroscopy or SS-RAB+CBCT (Ion endoluminal system). The primary endpoint, diagnostic yield, was defined per ATS 2024 consensus criteria (strict definition). Results: From June to November 2024, 78 patients with 127 PPLs were randomized to CB (39 patients) and RAB+CBCT (39 patients). Median lesion diameter was 11 mm [IQR 9–16], 18 (14.2%) lesions had a positive bronchus-sign, and 35 (27.6%) lesions were classified as pure ground-glass opacities. Diagnostic yield was 23.1% (9/39) for CB and 84.6% (33/39) for RAB+CBCT, yielding an absolute difference of 61.5% (95% CI, 44.1–78.9%, p<0.001). Among non-diagnostic CB cases, 92.9% (26/28) were successfully diagnosed through subsequent RAB+CBCT, either during the same anesthesia event or a separate procedure. Overall, 68 (53.5%) cases were diagnosed with lung cancer (50 [39.4%] with stage IA). The overall rate of adverse events were similar in both groups (p=0.09). 12-month follow-up for 7 (5.5%) lesions is ongoing. Conclusion: RAB with integrated CBCT offers a significantly higher diagnostic yield than CB, positioning it as a pivotal tool for early lung cancer diagnosis and a potential driver of stage shift.

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