Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer
2020年10月9日 更新者：Lunxu Liu、West China Hospital
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial
The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.
研究概览
详细说明
Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival.
Handling the tumor during a surgery may promote the release of CTCs into the bloodstream.
Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified.
This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.
研究类型
介入性
注册 (预期的)
60
阶段
- 不适用
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
-
-
Sichuan
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Chendu、Sichuan、中国、610041
- West China Hospital, Sichuan University
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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:
- Patients with stage I-IV lung cancer eligible for surgery
- Patients undergoing the completely thoracoscopic lobectomy
- The nodule size was more than 2.5 cm
- Patients consenting for intraoperative blood sampling
Exclusion Criteria:
- Patients who underwent primary wedge resection and open lobectomy
- Patients who received neoadjuvant therapy before surgery
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：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Vein ligation first
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
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During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
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有源比较器：Artery ligation first
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
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During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The changes of the level of circulating tumor cells in the peripheral blood
大体时间：Intraoperative
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The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest
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Intraoperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
3-year Progression-Free-Survival
大体时间：From date of the recruitment, assessed up to 36 months
|
From the date of recruitment until the date of progression of lung cancer assessed up to 36 months
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From date of the recruitment, assessed up to 36 months
|
|
失血
大体时间：手术过程中
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手术过程中失血
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手术过程中
|
|
Operative time
大体时间：During the surgery
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Operative time during the surgery
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During the surgery
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Length of stay
大体时间：From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days
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The length of patients staying in hospital from the date of checking in to the date of checking out
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From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days
|
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Morbidity
大体时间：Within 30 days after surgery
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Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.
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Within 30 days after surgery
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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
- 首席研究员：Lunxu Liu, M.D.,Ph.D.、West China Hospital
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
- Gall TM, Jacob J, Frampton AE, Krell J, Kyriakides C, Castellano L, Stebbing J, Jiao LR. Reduced dissemination of circulating tumor cells with no-touch isolation surgical technique in patients with pancreatic cancer. JAMA Surg. 2014 May;149(5):482-5. doi: 10.1001/jamasurg.2013.3643.
- Hansen E, Wolff N, Knuechel R, Ruschoff J, Hofstaedter F, Taeger K. Tumor cells in blood shed from the surgical field. Arch Surg. 1995 Apr;130(4):387-93. doi: 10.1001/archsurg.1995.01430040049007.
- Kurusu Y, Yamashita J, Hayashi N, Mita S, Fujino N, Ogawa M. The sequence of vessel ligation affects tumor release into the circulation. J Thorac Cardiovasc Surg. 1998 Jul;116(1):107-13. doi: 10.1016/s0022-5223(98)70248-x.
- Li F, Jiang G, Chen Y, Wang J. Curative Effects of Different Sequences of Vessel Interruption During the Completely Thoracoscopic Lobectomy on Early Stage Non-Small Cell Lung Cancer. Ann Thorac Cardiovasc Surg. 2015;21(6):536-43. doi: 10.5761/atcs.oa.15-00044. Epub 2015 Aug 18.
- Kozak A, Alchimowicz J, Safranow K, Wojcik J, Kochanowski L, Kubisa B, Pierog J, Grodzki T. The impact of the sequence of pulmonary vessel ligation during anatomic resection for lung cancer on long-term survival--a prospective randomized trial. Adv Med Sci. 2013;58(1):156-63. doi: 10.2478/v10039-012-0061-3.
- Refaely Y, Sadetzki S, Chetrit A, Simansky DA, Paley M, Modan B, Yellin A. The sequence of vessel interruption during lobectomy for non-small cell lung cancer: is it indeed important? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1313-20. doi: 10.1016/s0022-5223(03)00022-9.
- Ge MJ, Shi D, Wu QC, Wang M, Li LB. Observation of circulating tumour cells in patients with non-small cell lung cancer by real-time fluorescent quantitative reverse transcriptase-polymerase chain reaction in peroperative period. J Cancer Res Clin Oncol. 2006 Apr;132(4):248-56. doi: 10.1007/s00432-005-0059-3. Epub 2005 Dec 1.
- Yellin A, Sadetzki S, Simansky DA, Refaely Y, Chetrit A, Paley M. The sequence of vessel interruption during lobectomy: does it affect the amount of blood retained in the lobe? Eur J Cardiothorac Surg. 2007 Apr;31(4):711-3. doi: 10.1016/j.ejcts.2007.01.019. Epub 2007 Feb 15.
- Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with primary lung cancer. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):775-83. doi: 10.1093/icvts/ivu048. Epub 2014 Mar 11.
- Song PP, Zhang W, Zhang B, Liu Q, DU J. Effects of different sequences of pulmonary artery and vein ligations during pulmonary lobectomy on blood micrometastasis of non-small cell lung cancer. Oncol Lett. 2013 Feb;5(2):463-468. doi: 10.3892/ol.2012.1022. Epub 2012 Nov 9.
- Ackerman NB. Primary arterial ligation in resection of cancer of the colon. Rational and technic. Am J Surg. 1977 Jan;133(1):73-7. doi: 10.1016/0002-9610(77)90196-9.
- Wei S, Guo C, He J, Tan Q, Mei J, Yang Z, Liu C, Pu Q, Ma L, Yuan Y, Lin F, Zhu Y, Liao H, Wang W, Liu Z, Li Q, Jiang B, Li C, Xia L, Zhao K, Gan F, Cheng J, Wu Z, Wang Y, Lin Y, Kou Y, Che G, Chen L, Li J, Liu L. Effect of Vein-First vs Artery-First Surgical Technique on Circulating Tumor Cells and Survival in Patients With Non-Small Cell Lung Cancer: A Randomized Clinical Trial and Registry-Based Propensity Score Matching Analysis. JAMA Surg. 2019 Jul 1;154(7):e190972. doi: 10.1001/jamasurg.2019.0972. Epub 2019 Jul 17. Erratum In: JAMA Surg. 2019 Jun 12;:
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 (实际的)
2016年12月1日
初级完成 (实际的)
2018年5月31日
研究完成 (预期的)
2020年12月31日
研究注册日期
首次提交
2018年2月5日
首先提交符合 QC 标准的
2018年2月15日
首次发布 (实际的)
2018年2月19日
研究记录更新
最后更新发布 (实际的)
2020年10月12日
上次提交的符合 QC 标准的更新
2020年10月9日
最后验证
2020年10月1日
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.