Hongliang Hui, Haoran Miao, Fan Qiu, Huaming Li, Yangui Lin, Yiqian Zhang, Bo Jiang
{"title":"一项前瞻性随机临床试验：电磁导航引导与计算机断层扫描引导下经皮定位多发小肺结节的非劣效性比较。","authors":"Hongliang Hui, Haoran Miao, Fan Qiu, Huaming Li, Yangui Lin, Yiqian Zhang, Bo Jiang","doi":"10.1186/s12957-024-03606-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry Identifier: ChiCTR2200056734.</p>","PeriodicalId":23856,"journal":{"name":"World Journal of Surgical Oncology","volume":"22 1","pages":"323"},"PeriodicalIF":2.5000,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11608476/pdf/","citationCount":"0","resultStr":"{\"title\":\"Noninferiority comparison of electromagnetic navigation-guided versus computed tomography-guided percutaneous localization of multiple small pulmonary nodules: a prospective randomized clinical trial.\",\"authors\":\"Hongliang Hui, Haoran Miao, Fan Qiu, Huaming Li, Yangui Lin, Yiqian Zhang, Bo Jiang\",\"doi\":\"10.1186/s12957-024-03606-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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). 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Noninferiority comparison of electromagnetic navigation-guided versus computed tomography-guided percutaneous localization of multiple small pulmonary nodules: a prospective randomized clinical trial.
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.
期刊介绍：
World Journal of Surgical Oncology publishes articles related to surgical oncology and its allied subjects, such as epidemiology, cancer research, biomarkers, prevention, pathology, radiology, cancer treatment, clinical trials, multimodality treatment and molecular biology. Emphasis is placed on original research articles. The journal also publishes significant clinical case reports, as well as balanced and timely reviews on selected topics.
Oncology is a multidisciplinary super-speciality of which surgical oncology forms an integral component, especially with solid tumors. Surgical oncologists around the world are involved in research extending from detecting the mechanisms underlying the causation of cancer, to its treatment and prevention. The role of a surgical oncologist extends across the whole continuum of care. With continued developments in diagnosis and treatment, the role of a surgical oncologist is ever-changing. Hence, World Journal of Surgical Oncology aims to keep readers abreast with latest developments that will ultimately influence the work of surgical oncologists.
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