Real-Time Non-Invasive Localization for Multiple Lung Nodules

Effectiveness of Real-time Non-invasive Localization for Multiple Lung Nodules: a Pilot, Prospective, Randomized Clinical Trial

This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.

This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a real-time non-invasive localization. The study will be conducted between July 2024 and July 2025, involving 40 patients with multiple lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or real-time non-invasive localization. The primary outcome measure will be the successful resection rate of pulmonary nodules. Secondary outcome measures will include resection margins, changes in operative approach, intraoperative blood loss, operative time, postoperative hospitalization days, the placement of chest tubes, the duration of chest tube placement, and postoperative complications.

Inclusion Criteria:

1. the maximum diameter of the lesion on CT did not exceed 20 mm;
2. at least two pulmonary nodules identified;
3. pulmonary nodules showed pure ground-glass opacity (GGO) or mixed GGO on imaging;
4. the outer edge of nodules located between 5-20 mm from the nearest pleural surface.

Exclusion Criteria:

1. nodule location obstructed by the scapula, precluding needle access;
2. proximity of the nodule to major blood vessels, defined as within 2 cm;
3. requirement for localization of multiple pulmonary nodules.