Navigation of video-assisted thoracoscopic surgery using electromagnetic versus CT-guided localization (NOVEL): a study protocol for comparing procedural success and complication rates in a prospective, multicenter, randomized controlled, non-inferiority phase III trial.
Juntao Xie, Dingpei Han, Yang Zhou, Boxuan Huang, Can Ge, Agathe Seguin-Givelet, Ajay Wagh, Yeon Wook Kim, Weicheng Kong, Censong Xu, Hecheng Li, Jie Zhang
{"title":"Navigation of video-assisted thoracoscopic surgery using electromagnetic versus CT-guided localization (NOVEL): a study protocol for comparing procedural success and complication rates in a prospective, multicenter, randomized controlled, non-inferiority phase III trial.","authors":"Juntao Xie, Dingpei Han, Yang Zhou, Boxuan Huang, Can Ge, Agathe Seguin-Givelet, Ajay Wagh, Yeon Wook Kim, Weicheng Kong, Censong Xu, Hecheng Li, Jie Zhang","doi":"10.21037/tlcr-24-641","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The rise of low-dose computed tomography (LDCT) has increased the detection of small pulmonary nodules, demanding more effective localization techniques for their resection. Minimally invasive resection utilizing video-assisted thoracoscopic surgery (VATS) is a critical method for treating these nodules. However, traditional computed tomography (CT)-guided localization has limitations such as invasiveness and patient discomfort. The current gap in knowledge relates to the potential advantages of electromagnetic navigation bronchoscopy (ENB) in reducing complications and improving procedural efficiency. The NOVEL trial evaluates the non-inferiority of ENB-guided labeling against CT-guided puncture for lung nodule localization.</p><p><strong>Methods: </strong>This multicenter, randomized, controlled, non-inferiority phase III trial includes 156 participants across four Chinese hospitals, randomized to undergo either ENB-guided or CT-guided localization prior to VATS sub-lobar resection. Randomization is performed using sealed opaque envelopes to ensure allocation concealment. Primary outcomes are the procedural success rates and complication rates of both techniques, with secondary outcomes including procedure times and lesion margins.</p><p><strong>Discussion: </strong>The NOVEL trial aims to provide a detailed comparison of ENB-guided versus CT-guided localization for small pulmonary nodules. Establishing the safety and efficacy of the ENB method could significantly influence clinical practices and improve patient outcomes.</p><p><strong>Trial registration: </strong>This trial was registered with the Medical Research Registration Platform (https://www.medicalresearch.org.cn), registration number MR-31-24-018575.</p>","PeriodicalId":23271,"journal":{"name":"Translational lung cancer research","volume":"13 10","pages":"2838-2846"},"PeriodicalIF":4.0000,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535833/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational lung cancer research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/tlcr-24-641","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/17 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The rise of low-dose computed tomography (LDCT) has increased the detection of small pulmonary nodules, demanding more effective localization techniques for their resection. Minimally invasive resection utilizing video-assisted thoracoscopic surgery (VATS) is a critical method for treating these nodules. However, traditional computed tomography (CT)-guided localization has limitations such as invasiveness and patient discomfort. The current gap in knowledge relates to the potential advantages of electromagnetic navigation bronchoscopy (ENB) in reducing complications and improving procedural efficiency. The NOVEL trial evaluates the non-inferiority of ENB-guided labeling against CT-guided puncture for lung nodule localization.
Methods: This multicenter, randomized, controlled, non-inferiority phase III trial includes 156 participants across four Chinese hospitals, randomized to undergo either ENB-guided or CT-guided localization prior to VATS sub-lobar resection. Randomization is performed using sealed opaque envelopes to ensure allocation concealment. Primary outcomes are the procedural success rates and complication rates of both techniques, with secondary outcomes including procedure times and lesion margins.
Discussion: The NOVEL trial aims to provide a detailed comparison of ENB-guided versus CT-guided localization for small pulmonary nodules. Establishing the safety and efficacy of the ENB method could significantly influence clinical practices and improve patient outcomes.
Trial registration: This trial was registered with the Medical Research Registration Platform (https://www.medicalresearch.org.cn), registration number MR-31-24-018575.
期刊介绍：
Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
