NCT07395362

Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules

A Prospective Single-Arm Study Evaluating the Safety, Feasibility, and Perioperative Recovery of Robot-Assisted Percutaneous Ablation/Localization Combined With Non-Intubated Video-Assisted Thoracoscopic Surgery for Multiple Pulmonary Nodules

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Pulmonary Nodules

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-08-28
• Completion: 2026-10-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China