The goal of this clinical trial is to learn whether intraoperative longitude-latitude-depth three-dimensional localization (LLD localization) is non-inferior to preoperative CT-guided percutaneous lung puncture localization for identifying 0.8-2 cm peripheral pulmonary nodules in adults undergoing video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection. It will also evaluate the safety and perioperative effectiveness of the two localization methods. The main questions it aims to answer are:
1. Is the localization accuracy rate of LLD localization non-inferior to that of CT-guided percutaneous lung puncture localization? 2. Does LLD localization improve perioperative outcomes, including localization time, postoperative recovery, pain, quality of life, and perioperative complication rates?
Researchers will compare LLD localization with CT-guided percutaneous lung puncture localization to determine whether LLD localization provides comparable localization accuracy while reducing procedure-related complications and improving perioperative outcomes.
Participants will:
1. Be randomly assigned in a 1:1 ratio to either the LLD localization group or the CT-guided percutaneous lung puncture localization group. 2. Undergo pulmonary nodule localization using the assigned localization method. 3. Receive VATS-assisted sublobar resection following localization. 4. Be assessed for localization accuracy, perioperative complications, localization time, postoperative chest drainage tube removal time, oxygenation index, postoperative hospital stay, pain scores, and quality-of-life outcomes. 5. Complete follow-up assessments at 1, 3, and 6 months after surgery.
Clinically diagnosed pulmonary nodule by non-contrast chest CT.
Age 18 to 80 years.
Expected survival time of at least 12 months.
Single peripheral pulmonary nodule with a diameter between 0.8 cm and 2 cm.
Use of other localization methods or other surgical procedures.
Concurrent participation in another clinical study.
Pregnancy.
Unwillingness or inability to cooperate with participation in this study for any reason.
Parallel
Longitude-Latitude-Depth Localization
Procedure/SurgeryThe longitude-latitude-depth (LLD) localization method is a novel intraoperative three-dimensional pulmonary nodule localization technique developed for peripheral pulmonary nodules. Based on preoperative computed tomography (CT) imaging, the target lesion is characterized according to its longitudinal position, transverse position, and depth relative to the visceral pleural surface. During surgery, corresponding anatomical landmarks on the collapsed lung are identified, and the projected surface location and lesion depth are used to estimate the three-dimensional position of the target nodule. Localization is performed intraoperatively without preoperative transcutaneous puncture or placement of localization materials. The identified localization point is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection of the target lesion.
CT-Guided Percutaneous Lung Puncture Localization
Procedure/SurgeryCT-guided percutaneous lung puncture localization is a preoperative localization procedure performed under computed tomography guidance. A localization device is inserted through the chest wall into the lung parenchyma to mark the location of the target pulmonary nodule before surgery. Following localization, the position of the marker relative to the nodule is confirmed by CT imaging. The localization result is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection.
Localization Accuracy Rate
Localization accuracy rate is defined as the percentage of participants with successful localization, calculated as (number of successfully localized participants / total number of participants) × 100%. Localization is deemed successful if the actual distance between the localization point and the true nodule center, or its surface projection, is 1 cm or less. A distance exceeding 1 cm is classified as localization failure. After removal of the pulmonary nodule, measure the distance from the nodule center to the marked localization point with a ruler and record the value.
Perioperative Complication Rate
The perioperative complication rate is defined as the proportion of participants experiencing one or more procedure-related or surgery-related complications during the perioperative period. Complications include, but are not limited to, pneumothorax, hemothorax, pulmonary hemorrhage, hemoptysis, prolonged air leak, and other adverse events requiring medical intervention.
Localization Time
Localization time is defined as the time required to complete the pulmonary nodule localization procedure. For the LLD group, localization time is measured from initiation of intraoperative localization to successful identification of the localization point. For the CT-guided localization group, localization time is measured from initiation of the CT-guided localization procedure to completion of localization confirmation. The outcome will be reported in minutes.
Postoperative Chest Drainage Tube Removal Time
Chest drainage tube removal time is defined as the interval between completion of surgery and removal of the postoperative chest drainage tube according to institutional postoperative management criteria. The outcome will be reported in days. A shorter duration indicates faster postoperative recovery.
Oxygenation Index
The oxygenation index is calculated as the ratio of arterial oxygen partial pressure (PaO₂) to the fraction of inspired oxygen (FiO₂). Higher values indicate better pulmonary oxygenation function. The outcome will be reported as the PaO₂/FiO₂ ratio measured from arterial blood gas analysis.
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