Xie Juntao, Han Dingpei, Zhou Yang, Huang Boxuan, Ge Can, Seguin-Givelet Agathe, Wagh Ajay, Kim Yeon Wook, Kong Weicheng, Xu Censong, Li Hecheng, Zhang Jie
Department of Thoracic Surgery, Putuo People's Hospital, Tongji University, Shanghai, China.
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiaotong University of Medicine, Shanghai, China.
Transl Lung Cancer Res. 2024 Oct 31;13(10):2838-2846. doi: 10.21037/tlcr-24-641. Epub 2024 Oct 17.
The rise of low-dose computed tomography (LDCT) has increased the detection of small pulmonary nodules, demanding more effective localization techniques for their resection. Minimally invasive resection utilizing video-assisted thoracoscopic surgery (VATS) is a critical method for treating these nodules. However, traditional computed tomography (CT)-guided localization has limitations such as invasiveness and patient discomfort. The current gap in knowledge relates to the potential advantages of electromagnetic navigation bronchoscopy (ENB) in reducing complications and improving procedural efficiency. The NOVEL trial evaluates the non-inferiority of ENB-guided labeling against CT-guided puncture for lung nodule localization.
This multicenter, randomized, controlled, non-inferiority phase III trial includes 156 participants across four Chinese hospitals, randomized to undergo either ENB-guided or CT-guided localization prior to VATS sub-lobar resection. Randomization is performed using sealed opaque envelopes to ensure allocation concealment. Primary outcomes are the procedural success rates and complication rates of both techniques, with secondary outcomes including procedure times and lesion margins.
The NOVEL trial aims to provide a detailed comparison of ENB-guided versus CT-guided localization for small pulmonary nodules. Establishing the safety and efficacy of the ENB method could significantly influence clinical practices and improve patient outcomes.
This trial was registered with the Medical Research Registration Platform (https://www.medicalresearch.org.cn), registration number MR-31-24-018575.
低剂量计算机断层扫描（LDCT）的兴起增加了小肺结节的检出率，这就需要更有效的定位技术来进行切除。利用电视辅助胸腔镜手术（VATS）进行微创切除是治疗这些结节的关键方法。然而，传统的计算机断层扫描（CT）引导定位存在诸如侵入性和患者不适等局限性。目前在知识方面的差距涉及电磁导航支气管镜检查（ENB）在减少并发症和提高手术效率方面的潜在优势。NOVEL试验评估了ENB引导标记相对于CT引导穿刺在肺结节定位中的非劣效性。
这项多中心、随机、对照、非劣效性III期试验在中国的四家医院纳入了156名参与者，随机分为在VATS肺叶下切除术前接受ENB引导或CT引导定位。使用密封不透明信封进行随机分组以确保分配隐藏。主要结局是两种技术的手术成功率和并发症发生率，次要结局包括手术时间和病变边缘。
NOVEL试验旨在对ENB引导与CT引导的小肺结节定位进行详细比较。确定ENB方法的安全性和有效性可能会显著影响临床实践并改善患者预后。
本试验已在医学研究注册平台（https://www.medicalresearch.org.cn）注册，注册号为MR-31-24-018575。
