Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. This prospective observational cohort study aims to compare robot-assisted and conventional manual CT-guided puncture techniques for pulmonary nodule ablation. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture accuracy, radiation exposure, and procedure-related complications. The results will provide evidence regarding the clinical effectiveness and safety of robot-assisted puncture in pulmonary nodule ablation.
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety. This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses. The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
Study Type
OBSERVATIONAL
Enrollment
104
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Number of Needle Adjustments
Total number of needle adjustments required to achieve the planned puncture trajectory.
Time frame: During the procedure
Number of Intraoperative CT Scans
Total number of CT scans performed during the puncture procedure.
Time frame: During the procedure
Technical Success Rate
Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure.
Time frame: During the procedure
Puncture Deviation
Puncture deviation was measured as the distance (mm) between the planned target point and the actual needle tip position after puncture.
Time frame: During the procedure
Radiation Exposure
Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure.
Time frame: During the procedure
Procedure-Related Complications
Procedure-related complications were evaluated and graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system.
Time frame: Within 48 hours after the procedure
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