电磁导航系统引导下经皮 CT 同步肺活检和微波消融治疗肺结节：一项前瞻性、单中心、单臂临床研究。

Electromagnetic navigation system for computed tomography-guided synchronous percutaneous lung biopsy and microwave ablation of pulmonary nodules: a prospective, single-center, single-arm clinical study.

机构信息

Minimally Invasive Tumor Therapy Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.

Graduate School, Peking Union Medical College, Beijing, China.

出版信息

Int J Hyperthermia. 2024;41(1):2417761. doi: 10.1080/02656736.2024.2417761. Epub 2024 Oct 27.

DOI:10.1080/02656736.2024.2417761

PMID:39462519

Abstract

BACKGROUND

The purpose of this study was to clinically evaluate the safety and effectiveness of the electromagnetic navigation (EMN) system designed for computed tomography (CT)-guided synchronous percutaneous lung biopsy and microwave ablation (MWA) of pulmonary nodules.

METHODS

This prospective, single-center, single-arm clinical cohort study was conducted in Beijing Hospital from March 2023 to May 2023. Patients who underwent CT-guided synchronous percutaneous lung biopsy and MWA via the EMN system were prospectively enrolled in our study. All the interventional procedures were performed by the same interventional radiologist. The technical success rate, the technical efficacy rates of biopsy and MWA were assessed as the primary outcomes. Preoperative, intraoperative, and postoperative variables were also recorded and analyzed for each patient.

RESULTS

A total of 48 patients were enrolled in the study. The technical success rate was 100%. The technical efficacy rate of biopsy was 95.8% (46/48), and the technical efficacy rate of WMA was 100% (48/48) with no recurrence during follow-up. The total and subpleural needle trajectory length and distance error were 8.3 ± 2.6 cm, 3.6 ± 1.6 cm, and 1.84 ± 1.08 mm, respectively. The median numbers of needle adjustments and CT acquisitions were 1 (range 1-3) and 3 (range 3-5), respectively. The time to reach the target and procedure time were 4.4 ± 1.7 and 19.7 ± 5.2 min, respectively. The dose length product was 748.8 ± 221.8 mGy*cm. The median postoperative hospital stay was 1 (range 1-7) days. No major complications (grade ≥3) occurred and only seven minor complications (14.6%) occurred, including six cases of pneumothorax and one case of hemoptysis. The radiologists achieved high satisfaction scores after surgery.

CONCLUSION

The EMN system is feasible, safe and effective for CT-guided synchronous percutaneous lung biopsy and MWA of pulmonary nodules.

摘要

背景

本研究旨在临床评估专为 CT 引导同步经皮肺活检和微波消融（MWA）肺结节而设计的电磁导航（EMN）系统的安全性和有效性。

方法

这是一项 2023 年 3 月至 5 月在北京医院进行的前瞻性、单中心、单臂临床队列研究。前瞻性纳入接受 EMN 系统 CT 引导同步经皮肺活检和 MWA 的患者。所有介入操作均由同一位介入放射科医生完成。技术成功率和活检、MWA 的技术有效率作为主要结局进行评估。还记录和分析了每位患者的术前、术中、术后变量。

结果

本研究共纳入 48 例患者。技术成功率为 100%。活检的技术有效率为 95.8%（46/48），MWA 的技术有效率为 100%（48/48），随访期间无复发。总及亚胸膜针道长度和距离误差分别为 8.3±2.6cm、3.6±1.6cm 和 1.84±1.08mm。平均针调整次数和 CT 采集次数分别为 1（范围 1-3）和 3（范围 3-5）。到达目标的时间和手术时间分别为 4.4±1.7min 和 19.7±5.2min。剂量长度乘积为 748.8±221.8mGy*cm。术后中位住院时间为 1（范围 1-7）天。无严重并发症（≥3 级）发生，仅发生 7 例轻微并发症（14.6%），包括 6 例气胸和 1 例咯血。放射科医生术后满意度评分较高。