The Effectiveness of Robotic-assisted Navigation System for Preoperative Lung Nodule Localization: a Prospective, Single-center, Non-inferiority Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Localization Success Rate
研究概览
简要总结
This study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates.
详细描述
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a robotic-assisted navigation system for lung nodule localization compared to traditional manual CT-guided needle localization. The study will be conducted between June 2024 and December 2024, involving 100 patients with lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or robotic-assisted needle localization. The primary outcome measure will be the localization success rate, defined as the ability to accurately locate the nodule and guide the needle to the target site for biopsy or surgery. Secondary outcome measures will include procedural duration, the number of CT scans required, total dose-length product (DLP), first-pass success rate, localization success within a single needle adjustment, and complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Ⅰ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (Ⅱ) the presence of pure ground-glass opacity (GGO) or mixed GGO (solid to tumor ratio < 0.5) on CT with clinical or radiological suspicion of malignancy; (Ⅲ) patient with a peripheral nodule, located in the outer third of the lung parenchyma, with its edge situated at least 5 mm away from the pleural surface; (Ⅳ) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention.
排除标准
- •(Ⅰ) nodule location obstructed by the scapula, precluding needle access; (Ⅱ) proximity of the nodule to major blood vessels, defined as within 2 cm; (Ⅲ) requirement for localization of multiple pulmonary nodules.
研究组 & 干预措施
Freehand group
Manual CT-guided percutaneous needle localization of pulmonary nodules
干预措施: Manual needle localization (Procedure)
Robotic group
Robotic-assisted CT-guided percutaneous needle localization of pulmonary nodules
干预措施: Robotic-assisted needle localization (Device)
结局指标
主要结局
Localization Success Rate
时间窗: Immediately after needle localization and before surgery
The accuracy of nodule localization was designated as the primary outcome of the study. Successful localization was defined as a distance of less than 10 mm between the needle tip and the center of the nodule, with no displacement of the localization device between localization and surgery.
次要结局
- Procedure Duration(From patient positioning on the CT scanner to confirmation of successful needle insertion via final CT scan)
- Number of CT Scans Required for Localization(During the localization procedure)
- Total Dose-Length Product (DLP)(During the localization procedure)
- First-pass Success Rate(Immediately after the first needle insertion)
- Localization Success Rate within One Needle Adjustment(Immediately after one needle adjustment)
研究者
Jianxing He
Professor
The First Affiliated Hospital of Guangzhou Medical University