Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Puncture success rate of localization
研究概览
简要总结
This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.
详细描述
Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. Mixed reality (MR) technique aims to enhance the simple self-visual effect and facilitate visualization of the surrounding environment in any situation. The three-dimensional model can be visualized by MR technique through MR glasses. Investigators project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest, and then use this as a guide for percutaneous lung puncture localization. At the same time, investigators design an three-dimensional printing navigational template based on the 3D reconstruction model and place it on the surface of the body to help to guide the localization. This study is designed to evaluates the viability and accuracy of preoperative mixed reality technique combined with 3D printing navigational template guided localizing pulmonary nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a maximum target lung nodule (one or more) diameter ≤20 mm
- •a target nodule CTR <0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface >10 mm if the target nodule CTR was >0·
- •Plan to perform VATS lung wedge resection
排除标准
- •Inability to comply with research protocols or research procedures
- •Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease
- •Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture
- •Pregnant or lactating women
- •Other circumstances that the investigator believes are not suitable for enrollment
结局指标
主要结局
Puncture success rate of localization
时间窗: During surgery
The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.
次要结局
- Time of localization(During surgery)
研究者
Wen-zhao ZHONG
Principal Investigator
Guangdong Provincial People's Hospital
