Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- success rate of Stereoscopic Localization
研究概览
简要总结
This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first stage，participants will receive both Preoperative Stereoscopic Localization and Methylene Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic Localization for Wedge Resection.
详细描述
More and more Ground Glass Opacity（GGO）are detected because of the early screening.According to Fleischner Society, for some solid GGO, surgical resection should be performed if the solid component is larger than 5mm.With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades.However, localizing the small sized pulmonary nodules during VATS is challenging when there is no change in visceral pleura.
Several traditional techniques have been described to localize peripheral pulmonary nodules, including preoperative CT-guided tattooing with methylene blue, CT scan guided spiral/hook wire placement and marking with radio-opaque materials. The traditional marking method have its strong and weak points. For the strong point, It provide a credible and precise nodule location to the surgeon. For the weak points:(1)a potential risk of pneumothorax and hemothorax.(2)Methylene blue have a tendency to diffuse over a large area during surgical preparation until the nodule's location is confirmed.(3)The Preoperative localization technique would need more time for the Preoperative preparation, which would be reduce the transport's efficiency.(4)It would occupy the resource of CT's usage.(5)Some of the methods ,such as methylene blue, maybe interference with the Pathological diagnosis.(6)These methods are all invasive operation, would Cause the patients' psychological fear.
In order to avoid these weak points，the investigators use a new localization technique which has three basic steps: 1.Confirm the nodule's location in pulmonary segments. 2.Measure the distance between the nodule and anatomic landmarks on CT. 3. Estimate the changes of the distance between the nodule and anatomic landmarks after the alveolar atelectasis. The investigators have already succeed in some case.But,the further study is needed.Hence,the investigators designed a prospective study of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.Then,the investigators evaluate the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Eventhough only one group of participants，different investigators perform two kinds of localization techniques.
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative radiology revealed the solid component of GGO is larger than 5mm
- •Preoperative radiology revealed peripheral pulmonary nodule, with both size and depth less than 3 cm
- •Preoperative radiology revealed the distance from the lesion to the visceral pleura is larger than 5 mm
排除标准
- •Preoperative radiology revealed pneumonia or atelectasis
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Bleeding tendency or anticoagulant use
- •Pregnancy or breast feeding
- •Patient who can not sign permit
研究组 & 干预措施
Stereoscopic Versus Methylene Blue
In the same participant,we perform both Stereoscopic and Methylene Blue localization。Then，compare the distance between the methylene blue's anchor point and the location of lesion,stereoscopic Localization's anchor point and the location of lesion,methylene blue's anchor point and stereoscopic Localization's anchor point.
Post Hoc Multiple Comparisons
干预措施: Preoperative Stereoscopic Localization (Procedure)
结局指标
主要结局
success rate of Stereoscopic Localization
时间窗: 3 day
Success localization means that the distance from lession to anchor point is less than 3.0 cm.
次要结局
- Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate(3 day)
- Distance from A to B(3 day)
- Distance from A to C(3 day)
- Distance from B to C(3 day)
- The success rate of wedge resection(3 day)
- Postoperative adverse event incidence rate(1 months)
研究者
Wen-zhao ZHONG
Deputy director of Guangdong lung cancer institute
Guangdong Provincial People's Hospital