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

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.