形状感知机器人支气管镜联合锥形束CT在肺外周结节活检中的病灶验证工具研究
该单臂多中心前瞻性研究纳入200例可疑肺结节患者，评估形状感知机器人支气管镜（ssRAB）联合锥形束CT（CBCT）活检的诊断与安全性。结果显示CBCT确认工具入病灶（TIL）率达99.0%，严格诊断率85%，诊断准确率92.0%，恶性敏感度95.5%，严重不良事件发生率2%。
要点
- ssRAB联合CBCT对肺外周结节活检的TIL率达99.0%，诊断准确率92.0%。
- 结节中位大小13 mm，<20 mm结节诊断准确率88.2%，靠近胸膜者93.3%。
- 严重操作相关不良事件发生率2%，气胸发生率0.5%。
核心结论
- ssRAB联合CBCT可有效到达并活检小肺结节，包括叶间裂旁、胸膜旁和纵隔旁病灶，安全性良好。
研究设计与样本
- 单臂、多中心前瞻性研究，纳入200例可疑肺结节受试者，均接受ssRAB联合CBCT操作并随访。
主要发现
- 200例中198例成功活检，97%完成所需随访；结节中位大小13 mm，26.8%（60/224）有阳性支气管征，181个（80.8%）位于肺外2/3带。
- CBCT确认TIL达99.0%（198/200），严格诊断率85%（170/200），诊断准确率92.0%（184/200），恶性敏感度95.5%（147/154）。
- 结节<20 mm诊断准确率88.2%（172/195），距关键结构5 mm内为100%（11/11），距胸膜5 mm内为93.3%（56/60）。
- 严重操作相关不良事件4例（2%），其中气胸1例（0.5%）。
临床怎么用
- 对于肺外周小结节，可考虑采用ssRAB联合CBCT进行活检以提高病灶到达确认和诊断准确性。
- 对靠近叶间裂、胸膜或纵隔的结节，该技术仍可安全实施，但需注意气胸等不良事件风险。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
INTRODUCTION: Our aim was to evaluate the diagnostic and safety performance of shape-sensing robotic-assisted bronchoscopy (ssRAB) with cone beam CT (CBCT) for the biopsy of pulmonary nodules. Additional analysis was performed to assess outcomes for small nodules and those close to the fissure, pleura or mediastinum. METHODS: This single arm, multicentre prospective study enrolled 200 subjects with suspicious pulmonary nodules. Each subject underwent a ssRAB procedure with CBCT and was subsequently followed up. The primary outcome was tool-in-lesion (TIL) confirmed with CBCT. Further endpoints included diagnostic outcomes and rate of adverse events. RESULTS: Of 200 subjects recruited, 198 subjects had a successful biopsy (whereby lesion was reached and sample was taken) and 97% completed the required follow-up. The median size of the nodules was 13 mm; 26.8% (60/224) have a positive bronchus sign and 181 (80.8%) were located in the outer two-thirds of the lung. TIL was obtained in 99.0% (198/200). The strict diagnostic yield was 85% (170/200) with diagnostic accuracy of 92.0% (184/200) and sensitivity for malignancy of 95.5% (147/154). Diagnostic accuracy for nodules under 20 mm size, within 5 mm from a critical structure (eg, heart, aorta or main pulmonary artery) or from the pleura was 88.2% (172/195), 100% (11/11) and 93.3% (56/60), respectively. There were four (2%) serious procedure-related adverse events, with one patient (0.5%) suffering a pneumothorax. CONCLUSION: ssRAB with CBCT can effectively reach and biopsy small pulmonary nodules, including perifissural, peripleural and paramediastinal lesions with a strong safety profile. TRIAL REGISTRATION NUMBER: NCT05867953.
引用
- Chan LT, Lau KKW, Orton CM, et al. Tool in lesion verification of shape-sensing robotic-assisted bronchoscopy with cone beam CT in sampling peripheral pulmonary nodules. Thorax. 2026. PMID: 41391887. doi:10.1136/thorax-2025-223631
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。