Multiple Pulmonary Nodules
Conditions
Keywords
Multiple pulmonary nodules, Ground-glass nodules, Robot-assisted percutaneous ablation, CT-guided intervention, Non-intubated video-assisted thoracoscopic surgery NiVATS
Brief summary
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.
Detailed description
This is a prospective, single-arm interventional study conducted at a tertiary academic medical center. The study enrolls adult patients with multiple pulmonary nodules, including at least one dominant lesion that meets standard indications for thoracoscopic surgical resection and one or more additional nodules for which complete surgical resection is considered undesirable due to concerns regarding lung parenchymal preservation or procedural risk. All participants receive a predefined hybrid treatment strategy during the same hospitalization. Selected secondary pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated. The primary focus of this study is to assess perioperative safety and technical feasibility rather than comparative efficacy. Safety is evaluated by monitoring perioperative complications within 30 days after the procedure, while feasibility is assessed based on successful completion of the planned hybrid treatment strategy. Secondary observations include perioperative recovery parameters such as length of hospital stay, postoperative pain, and short-term clinical outcomes. This study is designed to provide prospective evidence regarding the clinical applicability of a hybrid, lung parenchyma-preserving approach for the management of multiple pulmonary nodules within the framework of current surgical and interventional practice.
Interventions
PROCEDUREHybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
This 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.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-arm study in which all enrolled participants receive a predefined hybrid treatment strategy combining robot-assisted percutaneous intervention and non-intubated video-assisted thoracoscopic surgery during the same hospitalization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 85 years at the time of enrollment. 2. Presence of multiple pulmonary nodules identified on chest computed tomography (CT). 3. At least one dominant pulmonary lesion meeting standard indications for thoracoscopic surgical resection based on radiologic assessment. 4. 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. 5. Determined by a multidisciplinary team (MDT) to be an appropriate candidate for the predefined hybrid treatment strategy. 6. Eligible for non-intubated video-assisted thoracoscopic surgery based on preoperative anesthetic evaluation (ASA physical status I-III). 7. Ability to understand the study procedures and provide written informed consent.
Exclusion criteria
1. Pulmonary nodules located centrally or adjacent to major airways, major vessels, or the heart, where safe percutaneous intervention is not feasible. 2. Pure ground-glass nodules with a maximum diameter \< 6 mm, for which active surveillance is recommended. 3. Clinical evidence of N1/N2 lymph node involvement or distant metastasis. 4. Severe cardiopulmonary disease, interstitial lung disease, or other conditions that preclude thoracoscopic surgery or anesthesia. 5. Coagulation disorders or ongoing anticoagulation therapy that cannot be safely discontinued. 6. Pregnancy or breastfeeding. 7. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Serious Complications | Within 30 days after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful completion rate of the planned hybrid treatment strategy | From the start of the percutaneous intervention to completion of the planned hybrid procedure during the same hospitalization, assessed up to 30 days | 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. |
Countries
China
Contacts
CONTACTYudong Zhang, MD
Outcome results
None listed