Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)
2019年10月11日 更新者：Yongxin Zhou、Shanghai Tongji Hospital, Tongji University School of Medicine
Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected.
The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified.
The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes.
It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.
研究概览
地位
未知
条件
详细说明
According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion.
The risk and benefit were informed and the informed consent of the subjects was signed.
The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer.
The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed.
Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.
研究类型
介入性
注册 (预期的)
120
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
-
-
Shanghai
-
Shanghai、Shanghai、中国、200000
- 招聘中
- Yongxin Zhou
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接触：
- Wenli Wang, Master
- 电话号码：13761295864
- 邮箱：Anderson840913@163.com
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接触：
- Shaorui Gu, scholor
- 电话号码：18351977377
- 邮箱：870005908@qq.com
-
-
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:
- (1) 18-70 years of age, regardless of gender;
- (2) From May 2019 to December 2021, patients with lung cancer who underwent thoracoscopic pneumonectomy (wedge-shaped, segment and lobe) were admitted to our hospital. Postoperative pathological diagnosis was non-small cell lung cancer. Preoperative pathological staging was T1a-bN0M0 and IA1-2 (pathological staging refers to UICC 8th Edition TNM staging standard for lung cancer).
- (3) In addition to routine examinations, all patients underwent enhanced chest CT, cranial CT/MRI, abdominal B-mode ultrasound, whole body bone isotope scan or PET-CT to exclude distant metastasis.
- (4) Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and sign the informed consent.
Exclusion Criteria:
- (1) Patients with other infectious diseases (inflammation, tuberculosis, etc.) in the thoracic cavity;
- (2) Patients are unwilling to accept the new technique of preserving pulmonary branch of vagus nerve during operation;
- (3) Clinical unstable patients with severe cardiovascular, renal and respiratory system;
- (4) Participated in other clinical trials within 30 days;
- (5) Other reasons why researchers think it is inappropriate to participate in the experiment.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
|
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
|
|
实验性的：No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
|
In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
|
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 |
|---|---|---|
|
cough after pulmonary resection
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
(1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
pulmonary infection
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative pneumonia should be considered if there are three or more of the following indicators:
If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics. |
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Atelectasis
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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hydrothorax
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative respiratory failure or ARDS or requiring tracheal intubation
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Tracheal intubation; Ventilator; ICU
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Operation time;
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Operation time;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Intraoperative bleeding volume;
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Intraoperative bleeding volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative drainage volume;
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative drainage volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative mortality
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative mortality
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative cardiovascular complications
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative cardiovascular complications
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Re-admission ICU rate;
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-admission ICU rate;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Time of stay in ICU;
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Time of stay in ICU;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Hospitalization days
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization days
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Hospitalization expenses
大体时间：From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization expenses
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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
- 研究主任：Yongxin zhou, Doctor、Tongji Hospital Affiliated to Tongji University
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
- Chen W, Zheng R, Zeng H, Zhang S. Epidemiology of lung cancer in China. Thorac Cancer. 2015 Mar;6(2):209-15. doi: 10.1111/1759-7714.12169. Epub 2015 Mar 2.
- Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
- Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
- Weijs TJ, Goense L, van Rossum PSN, Meijer GJ, van Lier AL, Wessels FJ, Braat MN, Lips IM, Ruurda JP, Cuesta MA, van Hillegersberg R, Bleys RL. The peri-esophageal connective tissue layers and related compartments: visualization by histology and magnetic resonance imaging. J Anat. 2017 Feb;230(2):262-271. doi: 10.1111/joa.12552. Epub 2016 Sep 23.
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)
2019年1月1日
初级完成 (预期的)
2021年1月30日
研究完成 (预期的)
2022年1月31日
研究注册日期
首次提交
2019年10月5日
首先提交符合 QC 标准的
2019年10月11日
首次发布 (实际的)
2019年10月14日
研究记录更新
最后更新发布 (实际的)
2019年10月14日
上次提交的符合 QC 标准的更新
2019年10月11日
最后验证
2019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.