电磁导航引导与计算机断层扫描引导经皮定位多发小结节的非劣效性比较：一项前瞻性随机临床试验。

Noninferiority comparison of electromagnetic navigation-guided versus computed tomography-guided percutaneous localization of multiple small pulmonary nodules: a prospective randomized clinical trial.

机构信息

Department of Thoracic Cardiovascular Surgery, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong, China.

出版信息

World J Surg Oncol. 2024 Nov 30;22(1):323. doi: 10.1186/s12957-024-03606-z.

DOI:10.1186/s12957-024-03606-z

PMID:39616331

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11608476/

Abstract

BACKGROUND

Accurate preoperative localization is a challenge in thoracoscopic surgery for multiple pulmonary nodules. In this study, we aimed to assess the accuracy and feasibility of electromagnetic navigation (EN)-guided percutaneous localization.

METHODS

We enrolled 50 patients with multiple pulmonary nodules for EN-guided (EN group) or CT-guided (CT group) localization. The primary outcome was the localization accuracy, and the primary analysis was to assess the noninferiority (noninferiority margin of 5 mm) of EN-induced localization deviation compared with that of CT-induced deviation. The secondary outcomes included the procedural duration, anxiety score, and incidence of complications.

RESULTS

Among the 50 patients randomized to the EN- and CT-guided groups, 24 patients (53 nodules) underwent EN-guided preoperative marking, and 25 patients (54 nodules) underwent CT-guided preoperative marking. The demographic, clinical, and radiological characteristics did not differ significantly between the groups (P > 0.05). Among these patients, the EN group was noninferior in terms of localization deviation compared with the CT group (9.0 [6.5] vs. 7.5 [6.0] mm; P = 0.33; absolute difference 0.9 [95% CI] 0.03-1.77]). Furthermore, the procedural duration was 16.3 (4.2) minutes for the EN group and 22.3 (8.2) minutes for the CT group (P = 0.002). Additionally, the EN group exhibited significant improvements compared with the CT group on the basis of the Amsterdam Preoperative Anxiety and Information Scale, particularly in relation to the S and C subscales' cumulative scores.

CONCLUSIONS

EN was found to be noninferior to CT in terms of localization accuracy, as it significantly decreased the procedural duration and relieved psychological stress for patients who underwent simultaneous surgery for multiple pulmonary nodules.

CLINICAL TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier: ChiCTR2200056734.

摘要

背景

在胸腔镜手术中，多个肺结节的准确术前定位是一个挑战。本研究旨在评估电磁导航（EN）引导经皮定位的准确性和可行性。

方法

我们纳入了 50 名患有多个肺结节的患者，进行 EN 引导（EN 组）或 CT 引导（CT 组）定位。主要结局是定位准确性，主要分析是评估 EN 诱导的定位偏差与 CT 诱导的偏差相比是否具有非劣效性（非劣效性边界为 5mm）。次要结局包括操作时间、焦虑评分和并发症发生率。

结果

在随机分配到 EN 和 CT 引导组的 50 名患者中，24 名患者（53 个结节）接受了 EN 引导术前标记，25 名患者（54 个结节）接受了 CT 引导术前标记。两组患者的人口统计学、临床和影像学特征无显著差异（P＞0.05）。在这些患者中，EN 组在定位偏差方面与 CT 组相比具有非劣效性（9.0[6.5] 与 7.5[6.0]mm；P=0.33；绝对差值 0.9[95%CI 0.03-1.77]）。此外，EN 组的操作时间为 16.3（4.2）分钟，CT 组为 22.3（8.2）分钟（P=0.002）。此外，EN 组在阿姆斯特丹术前焦虑和信息量表上与 CT 组相比有显著改善，特别是在 S 和 C 子量表的累积评分方面。