Comparative diagnostic performance of robotic, electromagnetic navigation, and fluoroscopy bronchoscopy for lung cancer in peripheral pulmonary lesions: a prospective, multicenter, parallel-controlled trial.

Abstract

Introduction: Peripheral pulmonary lesions (PPLs) are difficult to access bronchoscopically due to their distal location. Although robotic, electromagnetic navigation, and fluoroscopy-guided systems have been developed, inconsistent study designs have limited direct comparison of their diagnostic performance.

Objectives: This study aimed to compare the diagnostic performance and lesion-specific advantages of robotic bronchoscopy system (RBS), electromagnetic navigation bronchoscopy(ENB), and fluoroscopy bronchoscopy(FB) for PPLs.

Methods: In this multicenter, prospective, parallel-controlled trial, consecutive patients with suspected PPLs from 7 centers were assigned to the RBS, ENB or FB groups according to a predefined cyclic sequence for biopsy between 2019 and 2023. Subgroup analyses of diagnostic yield were performed according to lesion characteristics. Machine-learning models and a web-based platform were developed for clinical evaluation.

Results: A total of 270 patients were included, with 90 patients in each group. RBS achieved a higher overall diagnostic yield than ENB and FB (87.8%, 83.3% and 63.3%, respectively; P < 0.001). Strict diagnostic yield was also highest in the RBS group (81.1% vs 61.1% and 47.8%; P < 0.001). In the subgroup analysis, RBS performed better for 15-30 mm lesions and lesions within 15 mm of the pleura (P < 0.005), whereas ENB showed a diagnostic yield comparable to RBS for malignant, larger and solid lesions. Navigation and biopsy success rates in the RBS group were 100%, with more precise trajectories and lower displacement than the other two techniques (P < 0.001). Based on lesion characteristics, internally developed models (all AUC > 0.96) were integrated into a visualization platform to estimate the technique-specific diagnostic success for individualized PPLs.

Conclusion: This multicenter study demonstrates that RBS, ENB and FB have distinct diagnostic advantages across different PPL subgroups. RBS showed better diagnostic performance in selected challenging lesions, whereas ENB achieved comparable performance in malignant, solid, or larger lesions. The image-based prediction platforms may further support individualized selection of transbronchial navigation strategies for PPL or lung cancer diagnosis.