Wang Lei, Song Biao, Zhang Zheng, Bo Bing, Xiong Anwen, Ye Lingyun, Xie Dacheng, Li Juanjuan, Zhao Sha, Cai Chenlei, Wang Shanghu, Li Yuan, Song Qilong, Wang Zhaohua, Wang Mengjie, Cao Yanan, Yin Hui, Ji Kunpeng, Fang Chunfu, Shen Shu-Ting, Yang Yuchuan, Shi Zhe-Ni, Niu Bing, Liu Jian, Min Xuhong, Zhou Caicun
Department of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai 200433, China.
Department of Medical Imaging, Anhui Chest Hospital, Hefei 230022, China.
Lung Cancer. 2024 Dec;198:108025. doi: 10.1016/j.lungcan.2024.108025. Epub 2024 Nov 13.
Current percutaneous transthoracic needle biopsies (PTNB) navigation systems present challenges due to additional steps and limitations on the operating environment.
We developed a novel, registration-free navigation system for swift and precise CT-guided PTNB, eliminating the need for body surface markers and intraoperative registration. This study assesses its efficacy and safety.
A prospective study was conducted on participants aged 18-80 years prepared for PTNB at two clinical centers, from December 2021 to August 2022. The primary endpoint was the success rate of biopsies within 2 needle adjustments, and the secondary endpoint was the success rate within a single adjustment. Safety endpoints were defined by adverse events occurrence.
The study included 98 patients (median age, 64 years, IQR 54-69 years, 71 men). The primary endpoint achieved a biopsy success rate of 98.98 %, and the secondary endpoint demonstrated 97.96 %. The overall success rate was 98.98 %, significantly exceeding the target value of 85 % (P < 0.0001). The median number of CT scans was 3, significantly fewer than predicted for the manual puncture scheme [3 (IQR 3-3) to 8 (IQR 6-8), P < 0.0001]. The average procedure duration was 18.0 min (IQR: 14.0-29.0 min). The most common adverse events were hemorrhage (14 instances) and pneumothorax (8 instances). Other adverse events included elevated blood pressure, hemoptysis, and other common events.
Our registration-free navigation system proved to be an effective and safe system for assisting percutaneous lung biopsies in clinical practice.
由于额外的步骤以及对操作环境的限制，当前的经皮经胸针吸活检（PTNB）导航系统存在挑战。
我们开发了一种新颖的、无需配准的导航系统，用于快速精确的CT引导下PTNB，无需体表标记和术中配准。本研究评估其有效性和安全性。
2021年12月至2022年8月，在两个临床中心对18 - 80岁准备接受PTNB的参与者进行了一项前瞻性研究。主要终点是在两次针调整内活检的成功率，次要终点是单次调整内的成功率。安全终点由不良事件的发生来定义。
该研究纳入了98例患者（中位年龄64岁，四分位间距54 - 69岁，男性71例）。主要终点的活检成功率为98.98%，次要终点为97.96%。总体成功率为98.98%，显著超过目标值85%（P < 0.0001）。CT扫描的中位次数为3次，明显少于手动穿刺方案预测的次数[3（四分位间距3 - 3）至8（四分位间距6 - 8），P < 0.0001]。平均手术时间为18.0分钟（四分位间距：14.0 - 29.0分钟）。最常见的不良事件是出血（14例）和气胸（8例）。其他不良事件包括血压升高、咯血和其他常见事件。
我们的无需配准的导航系统在临床实践中被证明是一种有效且安全的辅助经皮肺活检的系统。
