The goal of this clinical trial is to evaluate the safety and feasibility of a predefined hybrid treatment strategy in patients with multiple pulmonary nodules who require surgical management of at least one dominant lesion. The strategy combines robot-assisted CT-guided percutaneous ablation and/or localization with non-intubated video-assisted thoracoscopic surgery (NiVATS) performed during the same hospitalization.
The main questions this study aims to answer are:
Is the hybrid treatment strategy associated with an acceptable rate of perioperative serious complications?
Can the planned combination of robot-assisted percutaneous intervention and NiVATS be completed successfully in a real-world clinical setting?
Participants will:
Undergo preoperative evaluation and multidisciplinary assessment;
Receive robot-assisted CT-guided percutaneous ablation and/or localization for selected pulmonary nodules;
Undergo non-intubated video-assisted thoracoscopic surgery for resection of the dominant pulmonary lesion;
Be followed for perioperative outcomes and short-term recovery up to 30 days after surgery.
Age 18 to 85 years at the time of enrollment.
Presence of multiple pulmonary nodules identified on chest computed tomography (CT).
At least one dominant pulmonary lesion meeting standard indications for thoracoscopic surgical resection based on radiologic assessment.
At least one additional pulmonary nodule for which complete surgical resection is considered undesirable due to lung parenchyma preservation concerns or procedural risk, and deemed suitable for robot-assisted CT-guided percutaneous intervention.
Pulmonary nodules located centrally or adjacent to major airways, major vessels, or the heart, where safe percutaneous intervention is not feasible.
Pure ground-glass nodules with a maximum diameter < 6 mm, for which active surveillance is recommended.
Clinical evidence of N1/N2 lymph node involvement or distant metastasis.
Severe cardiopulmonary disease, interstitial lung disease, or other conditions that preclude thoracoscopic surgery or anesthesia.
Single group
Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
Procedure/SurgeryThis intervention consists of a predefined hybrid procedural strategy performed during the same hospitalization. Selected pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant pulmonary lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated.
Perioperative Serious Complications
The proportion of participants who experience serious perioperative complications within 30 days after the procedure, defined as complications of Clavien-Dindo grade III or higher, including events requiring surgical, endoscopic, or radiologic intervention, intensive care management, or resulting in death.
Successful completion rate of the planned hybrid treatment strategy
Technical feasibility is defined as the proportion of participants in whom the planned hybrid treatment strategy-robot-assisted CT-guided percutaneous intervention followed by non-intubated video-assisted thoracoscopic surgery-is successfully completed without unplanned abandonment of the procedure. Conversion to conventional intubated anesthesia is permitted and will be recorded.
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