Real-time non-invasive localization in sub-lobar resection for small pulmonary nodules: a noninferiority randomized clinical trial.

Background: Sub-lobar resection is a well-established surgical approach for solitary pulmonary ground-glass opacity (GGO) lesions. However, conventional CT-guided percutaneous localization is associated with complications such as pneumothorax, hemothorax, and patient discomfort. To address these concerns, a novel real-time, non-invasive localization technique was developed. This study aimed to evaluate the effectiveness and safety of this innovative method for localizing small pulmonary nodules during sub-lobar resection.

Methods: A non-inferiority randomized clinical trial was conducted at the First Affiliated Hospital of Guangzhou Medical University from July 2022 to July 2023. Patients were randomized 1:1 to either non-invasive or CT-guided localization. The primary endpoint was the successful resection rate. Secondary endpoints included margin distance, surgical plan changes, conversion rate, intraoperative blood loss, chest tube placement duration, postoperative hospital stay, localization-related and postoperative complications, and 30-day postoperative mortality.

Results: Of the 440 randomized patients, 430 underwent surgery. The successful resection rate was comparable between the non-invasive and CT-guided groups (98.1 % vs. 98.6 %; P = 0.703). No significant differences were observed in margin distance, intraoperative blood loss, chest tube duration, postoperative hospital stay, or postoperative complication rates. Localization-related complications were significantly higher in the CT-guided group, including misplacement (9.8 %), puncture site pain (55.8 %), pneumothorax (42.3 %), and minor hemorrhage (30.2 %). No localization-related complications occurred in the non-invasive group.

Conclusions: The novel non-invasive localization technique demonstrated comparable effectiveness to CT-guided localization for sub-lobar resection, with significantly fewer localization-related complications, offering a safer alternative for managing small pulmonary nodules.