Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound (CT0007)
Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are usually found accidentally as discrete well emarginated pulmonary lesions found within the lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic. Most solitary lung nodules are benign; however these nodules can represent early stage lung cancer. The identification of malignant pulmonary nodules is important because they represent a potential form of curable lung malignancy. Every lung nodule should therefore be investigated for the possibility of malignancy.
Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies, ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also been shown to be able to locate nodules not visualized on spiral CT.
The use of intracavitary ultrasound has been suggested by many authors as a safe and effective method for localizing hard to find nodules. It is a real time technique with no associated complications, low cost, and has the potential to save operative time. Most importantly, it may be able to prevent conversion of VATS to open operations in cases where nodules are not visualizable or locatable using VATS techniques.
The use of intracavitary US as a localization method by surgeons intra-operatively could lead to better identification of nodules. Also, this technique could avoid performing multiple procedures on patients (CT guided targeting followed by surgery) and therefore is more cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used routinely during VATS procedures, increasing the chances of finding and localizing pulmonary nodules using minimally invasive techniques.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Quebec
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Monteal、Quebec、加拿大、H2L 4M1
- Centre Hospitalier de l'Université de Montréal
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection.
Exclusion Criteria:
- Inability to consent for the study.
- Patients less than 18 years old.
- Patients with pulmonary nodules easily located during VATS.
- Patients with tumours extending to visceral pleura or chest wall.
- Patients who have chest anatomy precluding VATS resection.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:1个
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intracavitary ultrasound done during surgical intervention
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The primary outcome is to confirm the validity of surgeon-performed intra-operative intracavitary ultrasound as a localization method for difficult to visualize pulmonary nodules during VATS procedures.
大体时间:3-6 months
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3-6 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT.
大体时间:3-6 months
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3-6 months
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To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy.
大体时间:6 months
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6 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
intracavitary ultrasound的临床试验
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Centre Hospitalier Universitaire de la Réunion招聘中
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology; St. Olavs Hospital完全的
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Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI); University of California, San Diego; GE Healthcare; National Institutes... 和其他合作者完全的
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Connolly Hospital BlanchardstownRoyal College of Surgeons, Ireland; European Society for Trauma and Emergency Surgery; Modular...完全的