Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT)

摘要

Abstract Rationale Robotic-assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Although both platforms are routinely used in clinical practice, comparative effectiveness data are lacking. Objectives We sought to compare the effectiveness of robotic-assisted and electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. Methods In an investigator-initiated, single-center, cluster-randomized noninferiority trial, we assigned patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion to either robotic-assisted or electromagnetic navigational bronchoscopy. The cluster randomization unit was the operating room in which patients were scheduled. The primary outcome was the diagnostic yield of the procedure, defined as the proportion of cases yielding lesional tissue. Secondary and safety outcomes included procedure duration and complications. Measurements and Main Results Among the 411 patients included in the modified intention-to-treat analysis, lesional tissue was obtained in 158 of 203 (77.8%) patients in the robotic-assisted group and 157 of 208 (75.5%) patients in the electromagnetic group; the P value for noninferiority was 0.007. The median duration of bronchoscopy was 37 minutes in the robotic-assisted group and 32 minutes in the electromagnetic group (difference, 5 min; 95% confidence interval = 2.0–7.7). Pneumothorax occurred in 4 patients in the robotic-assisted group and 6 patients in the electromagnetic group. Conclusions In patients undergoing bronchoscopy for the evaluation of a peripheral pulmonary lesion, the diagnostic yield of robotic-assisted bronchoscopy was not inferior to that of electromagnetic navigation bronchoscopy. Clinical trial registered with www.clinicaltrials.gov (NCT 05705544).