Single-Encounter Augmented Reality–Guided Localization for Resection of Suspected Early-Stage Lung Cancer

Importance: Preoperative localization is often required to achieve successful sublobar resection with adequate margins for computed tomography (CT)-detected pulmonary nodules suspicious for early-stage lung cancer. Conventional CT-guided localization involves a multiple-encounter workflow that may cause pain, radiation exposure, and complications. Objective: To determine whether a single-encounter augmented reality (AR)-guided percutaneous localization strategy is noninferior to standard multiple-encounter CT-guided localization for achieving successful sublobar resection. Design, Setting, and Participants: This randomized noninferiority trial was conducted at 5 centers in China between August 8, 2024, and September 30, 2025. Among 296 randomized patients, 270 were included in the modified intention-to-treat analysis (134 in AR; 136 in CT). Exclusion criteria included multiple nodules (≥2), unsafe percutaneous access, comorbidities limiting participation, or consent withdrawal. Interventions: Single-encounter AR-guided percutaneous localization performed in the operating room under general anesthesia vs multiple-encounter CT-guided percutaneous localization performed in the CT suite under local anesthesia followed by transfer to the operating room for surgery. Main Outcomes and Measures: The primary outcome was successful sublobar resection, defined as R0 resection with protocol-defined margin adequacy according to nodule type. Secondary outcomes included localization accuracy, radiation exposure, complications, patient-reported outcomes, and procedural efficiency. Results: The median (IQR) age of the population was 59 (50-67) years, and 172 participants (63.7%) were female. Successful sublobar resection occurred in 132 of 134 AR-guided procedures (98.5%) and 135 of 136 CT-guided procedures (99.3%) (risk difference, -0.8 percentage points; 95% CI, -2.7 to 3.9), meeting the noninferiority criterion. There was no statistically significant difference in localization error between groups (median [IQR]: AR group, 3.0 [0.0 to 5.0]; CT group, 3.0 [2.0 to 6.0]). AR guidance was associated with lower radiation exposure (median [IQR], 456.50 [378.75 to 631.85] vs 1260.11 [1026.48 to 1544.53] mGy · cm; P < .001), lower preoperative pain (median [IQR] numeric rating scale, 0 [0-0] vs 5 [4-6]; P < .001), shorter puncture time (median [IQR], 0.63 [0.50 to 0.83] vs 6.50 [5.00 to 8.75] minutes; P < .001), and shorter localization-to-incision interval (median [IQR], 2.00 [1.50 to 2.00] vs 33.50 [18.00 to 63.00] minutes; P < .001). Pneumothorax occurred in 40 of 136 CT-guided cases (29.4%). Conclusions and Relevance: In this randomized clinical trial, single-encounter AR-guided localization was noninferior to CT-guided localization for achieving successful sublobar resection and was associated with reduced radiation exposure, lower pain, shorter puncture time, and a shorter localization-to-incision interval, supporting its use as an alternative to CT-guided localization. Trial Registration: ClinicalTrials.gov Identifier: NCT06548451.