About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery