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

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.