Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Accuracy of nodule localization
研究概览
简要总结
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18years of age;
- •There was no distant metastasis in preoperative clinical evaluation;
- •The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
- •Target lung nodule diameter ≤ 2cm
- •The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
- •preoperative ECOG physical state score 0/1;
- •Volunteer to participate in the study and sign the informed consent form.
排除标准
- •More than two lung nodules need to be removed at the same time.
- •The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
- •The patient has uncontrollable mental illness and cannot make subjective assessment.
- •After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
- •After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
- •At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.
结局指标
主要结局
Accuracy of nodule localization
时间窗: 30 minutes
The deviation between the local quantizer and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
次要结局
- Radiation exposure dose(30 minutes)
- Postoperative puncture pain assessment(7 days)
- Operation duration(30 minutes)
- Incidence of complications(7 days)
研究者
Xinghua Cheng
MD
Shanghai Chest Hospital