Pulmonary Nodules
Conditions
Keywords
Pulmonary Nodules, Robot-Assisted Puncture, CT-Guided Ablation, Robotic Navigation, Thermal Ablation, Cryoablation
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation. * Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice. * Written informed consent provided.
Exclusion criteria
* Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures. * Previous thoracic surgery or local treatment affecting puncture planning. * Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation. * Pregnancy. * Inability or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Adjustments | During the procedure | Total number of needle adjustments required to achieve the planned puncture trajectory. |
| Number of Intraoperative CT Scans | During the procedure | Total number of CT scans performed during the puncture procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | During the procedure | Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure. |
| Puncture Deviation | During the procedure | Puncture deviation was measured as the distance (mm) between the planned target point and the actual needle tip position after puncture. |
| Radiation Exposure | During the procedure | Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure. |
| Procedure-Related Complications | Within 48 hours after the procedure | Procedure-related complications were evaluated and graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system. |
Countries
China
Outcome results
None listed