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临床试验/NCT00323089
NCT00323089已完成不适用

Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance: a Pilot Study

University of British Columbia2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2003年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
2
主要终点
pulmonary nodule excision with microcoil

研究概览

简要总结

The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.

The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.

详细描述

Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • subcentimetre lung nodule

排除标准

  • 未提供

研究组 & 干预措施

Surgical Arm

Experimental

Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)

干预措施: microcoil insertion and excision (Procedure)

结局指标

主要结局

pulmonary nodule excision with microcoil

时间窗: 6 years

Thoracotomy and excision rates

次要结局

  • Recurrence and death from lung cancer(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Finley

Principal Investigator

University of British Columbia

研究点 (2)

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