马上注册，阅读更多内容，享用更多功能！
您需要 登录 才可以下载或查看，没有账号？立即注册 
×
P79. Navigation of Video-Assisted Thoracoscopic Surgery Using Electromagnetic Versus CT-Guided Localization for Pulmonary Nodules: Interim Analysis from the NOVEL Trial
Objective: Electromagnetic navigational bronchoscopy (ENB)-guided dye marking or CT-guided localization are techniques used for localization, prior to thoracoscopic resection. Although some retrospective studies have evaluated this technique, there have not been any multicenter randomized controlled studies comparing both approaches. The NOVEL trial (Navigation of video-assisted thoracoscopic surgery using electromagnetic versus CT-guided localization) is a multicenter, randomized, non-inferiority phase III trial comparing ENB-guided and CT-guided preoperative localization.
Methods: Success rate (defined as localization marker to nodule closest distance ≤10mm) is the primary end point. Non-inferiority was defined as no statistically significant difference within the predefined 10% margin. A total of 156 patients are planned for enrollment, with 115 patients who have currently completed the protocol.
Results: This multicenter trial was conducted across five selected hospitals. A total of 122 patients were screened, and 115 patients were included in this interim analysis (ENB group 57 patients and CT group 58 patients). Success rate was 79.17% in the CT-guided group and 78.95% in the ENB-guided group. The mean marker-to-nodule closest distance was 5.8 ± 5.9 mm in the ENB group vs. 7.1 ± 8.0 mm in the CT group (p = 0.351). Complications differed significantly, with a rate of 13.8% in the CT, while no complications were reported in the ENB group. Subgroup analyses showed no significant associations between success rate and variables such as nodule size, nodule type, lobe location, or specific position of the nodule within the lung. Outer one-third nodule had higher success rate from CT localization, and middle or inner one-third nodule had slightly higher accuracy from ENB. Localization time averaged 9.33 ± 3.81 minutes in the CT group (does not count the time to transfer the patients between CT room and OR) vs. 18.53 ± 8.23 minutes in the ENB group (p < 0.001).
Conclusions: In our interim analysis, ENB-guided localization showed comparable accuracy to CT-guided techniques, meeting non-inferiority criteria for procedural success. These findings suggest that ENB offers a viable alternative to CT guidance, with advantages such as performance under general anesthesia, reduced transfer time to the OR, and efficient VATS sublobar resections. Further accrual is ongoing, and final results are awaited.
|
