Intraoperative Ultrasonographic Localization of Pulmonary Nodules in Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- The accuracy rate of localization
研究概览
简要总结
This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).
详细描述
The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients who are older than 18 year-old.
- •Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.
- •Patients who have good compliance and sign informed consent.
排除标准
- •Patient with severe asthma and pulmonary fibrosis.
- •Refusal of participation.
- •Severe cardiopulmonary dysfunction and other indications that can't receive VATS.
结局指标
主要结局
The accuracy rate of localization
时间窗: one year
The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.
次要结局
- Correlation of distance between the lesion and pleura and localization(one year)
- Time of localization(one week)
- Correlation of lesion size and localization(one year)
研究者
Xu Lei
Chief physician
Shanghai Chest Hospital