The First Affiliated Hospital of Guangzhou Medical University
Phase
Not applicable
Started
2026-02-28
Last updated
2026-02-09
Condition(s) studied
Multiple Pulmonary Nodules
Investigational drug(s) / intervention(s)
Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
Hybrid 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.
Study 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;
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
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of GZMU
Guangzhou
China
More The First Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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