Video-assisted Thoracoscopic Surgery for Stage IIIA Non-Small Cell Lung Cancer
Feasibility of Video-Assisted Thoracoscopic Surgery for Clinical Stage IIIA Non-Small Cell Lung Cancer
The purpose of this study is to examine the feasibility of video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer.
Success is defined as VATS major pulmonary resection with SND without conversion.
If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.
研究概览
详细说明
Video-assisted or minimally invasive surgery has become the standard approach for many abdominal surgical operations such as cholecystectomy and fundoplication.
With respect to the thorax, video-assisted thoracoscopic surgery (VATS) is the accepted technique for biopsy of the lung and pleura and surgical treatment of pneumothorax.
A VATS lobectomy with systematic node dissection (SND) for non-small cell lung cancer (NSCLC) has been gradually introduced by many thoracic surgeons since it was first performed in 1995 by McKenna and associates.
They reported that the survival rate for stage I lung cancer is similar between lobectomies done by VATS and by thoracotomy.
Although minimally invasive surgery certainly sounds good, it is problematic if it decreases patient's safety or the oncological treatment's effect.
Hence, the feasibility and safety of SND by VATS remain controversial.
In many institutions, the indication for VATS major pulmonary resection is limited to clinical stage I or II.
For the application of the procedure to clinical stage IIIA, it remains controversial.
Recently, Watanabe et al. did a retrospective study aimed at determining the outcome of patients with cN0-pN2 NSCLC who underwent VATS major pulmonary resection with SND versus the outcome after major pulmonary resection with SND by open thoracotomy.
It demonstrated that VATS major pulmonary resection with SND was a feasible approach to management of cN0-pN2 NSCLC without loss of curability.
It was unnecessary to convert the VATS approach to thoracotomy in order to do SND even if pN2 disease is revealed during VATS major pulmonary resection.
The purpose of this study is to know whether VATS major pulmonary resection with SND for clinical stage IIIA non-small cell lung cancer is possible.
研究类型
介入性
注册 (预期的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510120
- 招聘中
- Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
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接触：
- Daoyuan Wang, MD
- 电话号码：+86-20-83337792
- 邮箱：wangdy@vip.163.com
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接触：
- Wenlong Shao, MD
- 电话号码：+86-20-83337792
- 邮箱：myfriends2003@126.com
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首席研究员：
- Jianxing He, MD, FACS
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- Stage IIIA (T1-3, N2, M0): N2 disease confirmed by any of the following: Mediastinoscopy; Bronchoscopy with fine-needle aspiration or esophagoscopy; or PET scan
- ECOG performance status 0-1
- Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
- Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
- Renal: Creatinine clearance greater than 60 ml/min
- Cardiovascular: Cardiac function normal
Exclusion Criteria:
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer (Success is defined as VATS major pulmonary resection with SND without conversion).
大体时间：2 month
|
2 month
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
大体时间：6 months
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Jianxing He, MD, FACS、Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Watanabe A, Mishina T, Ohori S, Koyanagi T, Nakashima S, Mawatari T, Kurimoto Y, Higami T. Is video-assisted thoracoscopic surgery a feasible approach for clinical N0 and postoperatively pathological N2 non-small cell lung cancer? Eur J Cardiothorac Surg. 2008 May;33(5):812-8. doi: 10.1016/j.ejcts.2008.01.064. Epub 2008 Mar 14.
- He J, Yang Y, Chen M. [Lobectomy by video-assisted thoracoscopic surgery]. Zhonghua Wai Ke Za Zhi. 1996 Feb;34(2):76-8. Chinese.
- Shao WL, Liu LX, He JX, Yang YY, Chen HZ, Wu ZF, Wei B, Yin WQ, Yang DK. [Bronchial sleeve resection and reconstruction of pulmonary artery by video-assisted thoracic small incision surgery for central lung cancer: a report of 139 cases]. Zhonghua Wai Ke Za Zhi. 2007 Nov 15;45(22):1530-2. Chinese.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年12月1日
初级完成 (预期的)
2009年8月1日
研究完成 (预期的)
2009年12月1日
研究注册日期
首次提交
2009年3月13日
首先提交符合 QC 标准的
2009年3月13日
首次发布 (估计)
2009年3月16日
研究记录更新
最后更新发布 (估计)
2010年2月2日
上次提交的符合 QC 标准的更新
2010年2月1日
最后验证
2009年3月1日
更多信息
与本研究相关的术语
其他研究编号
- FAHG20081202
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.