Single-Encounter Augmented Reality–Guided Localization for Resection of Suspected Early-Stage Lung Cancer: A Randomized Clinical Trial
Mené en Chine sur 270 patients présentant des nodules pulmonaires suspects (âge médian : 59 ans ; 63,7 % de femmes), cet essai randomisé multicentrique évalue la non-infériorité, du point de vue de la réussite d'une résection sous-lobaire, d'une localisation percutanée guidée par réalité augmentée en une seule étape par rapport à une localisation guidée par tomodensitométrie en plusieurs étapes
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.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.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.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.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.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%).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.ClinicalTrials.gov Identifier: NCT06548451
JAMA Surgery , résumé, 2026