Song Zuodong, Li Yin, Tian Qing, Sun Chao, Liu Hongfeng, Chong Kongyong, Zhang Qian, Chen Jianeng, Li Pengchong, Song Liwei, Tosi Davide, Kim Min P, Lin Zhebing, Luo Qingquan, Yu Lingming, Cheng Xinghua
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Thoracic Surgery, the First Hospital of Hebei Medical University, Hebei, China.
Int J Surg. 2025 Apr 1;111(4):2933-2941. doi: 10.1097/JS9.0000000000002308.
HYPOTHESIS: This study hypothesized that augmented reality (AR) technology has comparable accuracy and safety to conventional CT localization in guiding percutaneous transthoracic lung puncture (PTLP) to localize small pulmonary nodules. METHODS: This study was a prospective, non-inferiority randomized clinical trial. Patients were randomly assigned between 23 May 2023, and 26 September 2023. Patients with small peripheral lung nodules (≤2 cm) were recruited. Patients were randomly assigned to either the CT-guided PTLP group or the AR-guided PTLP group, with a 1:1 allocation ratio. The primary outcome was the accuracy of lung nodule localization measured by localization error. The secondary outcomes included procedure duration, radiation exposure dosage and complications. RESULTS: A total of 70 patients underwent either CT- or AR-guided lung nodule localization and subsequent surgeries. Localization error was smaller in the AR-guided group than in the CT-guided group (mean ± SD, 3.1 ± 4.0 mm vs. 5.4 ± 4.2 mm, P = 0.026). The mean difference of localization errors was -2.3 mm (95% CI: - 4.2 to -0.3 mm, P < 0.001 for non-inferiority). Compared to the CT-guided group, the AR-guided group demonstrated significantly lower radiation exposure (mean ± SD, 421 ± 168 vs. 694 ± 229 mGy × cm, P < 0.001) and shorter localization procedure duration (mean ± SD, 8.8 ± 2.3 vs. 14.1 ± 1.8 minutes, P < 0.001), with no statistical difference in complications. CONCLUSIONS: The accuracy of the AR-guided approach is comparable to that of the CT-guided approach in localizing small lung nodules. Furthermore, the utilization of AR technology has been demonstrated to reduce procedural time and minimize radiation exposure for patients.
假设:本研究假设在引导经皮经胸肺穿刺(PTLP)定位小肺结节方面,增强现实(AR)技术与传统CT定位具有相当的准确性和安全性。 方法:本研究为前瞻性、非劣效性随机临床试验。患者于2023年5月23日至2023年9月26日期间被随机分组。招募了外周小肺结节(≤2 cm)的患者。患者以1:1的分配比例被随机分配到CT引导下PTLP组或AR引导下PTLP组。主要结局是通过定位误差测量的肺结节定位准确性。次要结局包括手术持续时间、辐射暴露剂量和并发症。 结果:共有70例患者接受了CT或AR引导下的肺结节定位及后续手术。AR引导组的定位误差小于CT引导组(均值±标准差,3.1±4.0 mm对5.4±4.2 mm,P = 0.026)。定位误差的平均差值为-2.3 mm(95%CI:-4.2至-0.3 mm,非劣效性检验P<0.001)。与CT引导组相比,AR引导组的辐射暴露显著更低(均值±标准差,421±168对694±229 mGy×cm,P<0.001),定位手术持续时间更短(均值±标准差,8.8±2.3对14.1±1.8分钟,P<0.001),并发症方面无统计学差异。 结论:在定位小肺结节方面,AR引导方法的准确性与CT引导方法相当。此外,已证明使用AR技术可减少手术时间并将患者的辐射暴露降至最低。
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