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内科胸腔镜下氩气刀肺减容治疗慢阻肺的有效性与安全性——前瞻性单臂多中心研究
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注册号:

Registration number:

ChiCTR1900027822 

最近更新日期:

Date of Last Refreshed on:

2019-11-30 

注册时间:

Date of Registration:

2019-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

内科胸腔镜下氩气刀肺减容治疗慢阻肺的有效性与安全性——前瞻性单臂多中心研究 

Public title:

Efficacy and safety of argon knife lung volume reduction under thoracoscope in the treatment of COPD: a prospective, single arm, multicenter study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

内科胸腔镜下氩气刀肺减容治疗慢阻肺的有效性与安全性——前瞻性单臂多中心研究 

Scientific title:

Efficacy and safety of argon knife lung volume reduction under thoracoscope in the treatment of COPD: a prospective,sing arm, multicenter study 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

金龙伟 

研究负责人:

冯起校 

Applicant:

Longwei Jin 

Study leader:

Qixiao Feng 

申请注册联系人电话:

Applicant telephone:

+86 18520088100 

研究负责人电话:

Study leader's telephone:

+86 18520088212 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

xuebao2005@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

cxhfqx@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

广东省广州市海珠区石榴岗路13号大院 

研究负责人通讯地址:

广东省广州市海珠区石榴岗路13号大院 

Applicant address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China  

Study leader's address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China  

申请注册联系人邮政编码:

Applicant postcode:

510315 

研究负责人邮政编码:

Study leader's postcode:

510315 

申请人所在单位:

南方医科大学中西医结合医院 

Applicant's institution:

Integrated Hospital of Traditional Chinese Medicine,Southern Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

NFZXYEC-2019-007 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南方医科大学中西医结合医院医学伦理委员会 

Name of the ethic committee:

Institutional Review Board of Integrated Hospital of Traditional Chinese Medicine, Southern Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-23 

伦理委员会联系人:

李爱荣 

Contact Name of the ethic committee:

Airong Li 

伦理委员会联系地址:

广东省广州市海珠区石榴岗路13号 

Contact Address of the ethic committee:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-61650040 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

nfzxyec@163.com 

研究实施负责(组长)单位:

南方医科大学中西医结合医院 

Primary sponsor:

Integrated Hospital of Traditional Chinese Medicine,Southern Medical University 

研究实施负责(组长)单位地址:

广东省广州市海珠区石榴岗路13号大院 

Primary sponsor's address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学中西医结合医院

具体地址:

海珠区石榴岗路13号大院

Institution
hospital:

Integrated Hospital of Traditional Chinese Medicine, Southern Medical University

Address:

13 Shiliugang Road, Haizhu District

经费或物资来源:

经费物资自筹 

Source(s) of funding:

Self-raised 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

COPD 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

内科胸腔镜下氩气刀肺减容治疗慢阻肺的有效性、安全性、可操作性,为肺减容术治疗提供一种新的方式和技术。在内科胸腔镜下,行氩等离子凝固肺大疱减容术,简单安全,创伤小,经济性高,故开展此技术能解决临床问题,患者能从中获益,且易广泛推行。但其有效性和安全性需要更多的数据支持,因此,进行前瞻性研究能确定科学性和客观性。 

Objectives of Study:

The aim of current study is to confirm the efficacy, safety, and feasibility of argon knife lung volume reduction under thoracoscope in the treatment of COPD so as to provide a novel technique in lung volume reduction surgery. With the guide of thoracoscope,argon plasma can coagulate bullae to reduce lung volume with the advantages of simple manipulationn,minimal trauma,less spending which can solve clinical problems and should be widely used to benefit more patients.However, more data is needed to prove its efficacy, safety, and feasibility.Therefore, performing a prospective study should meet the current need. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 诊断COPD明确(根据中国慢性阻塞性肺疾病诊治中国指南(2013年修订版)诊断标准。) 2. 高分辨率CT示胸膜下肺大泡线径6cm以上,为单个或多个连续肺大泡叠加数值,或高分辨率CT示病灶部位显著过度充气,呈非均质肺气肿,吸气相平均CT值<-960Hu,病灶周围存在相对正常被压缩的肺组织。 3. 年龄>18岁,<75岁。 4. 患者知情同意参加本研究,能够配合完成要求的随访访视。 

Inclusion criteria

1. Meet the diagnostic criteria of COPD according to China national guideline for the diagnosis and treatment of Chronic Obstructive Pulmonary Disease (revised edition 2013) 2.The diameter of either one bulla or the sum of multiple continuous bullae is greater than 6cm with over-ventilation in lesion site under HRCT.The average CT value during inhale phase is less than -960Hu.The lesion site is surrounded with compressed lung tissue. 3. Between 18 and 75 years old. 4.Patients who are fully informed for the current study and willingness to cooperate with the follow-up. 

排除标准:

1. 低流量吸氧时(≤3L/分),动脉血氧分压<60mmHg。 2. 慢性阻塞性肺疾病急性加重期。 3. CT提示广泛胸膜粘连及胸膜增厚。 4. 凝血功能异常不宜内科胸腔镜手术者。 5. 血小板 < 40×10^9/L。 6. 合并感染不宜内科胸腔镜手术者。 7. 严重器质性心脏病、心律失常、心功能不全者。 8. 患者有全身性疾病或肿瘤,并且预计研究期间生存时间会受影响。 9. 孕妇。 10. 患者正在在参加过其他药物或器械的研究,或结束后的90天内。 11. 研究者认定其他不合适情况。 

Exclusion criteria:

1. PO2<60mmHg with low liter flow rate of nasal O2 ( <= 3L/min); 2. AECOPD; 3. Pleural adhesions or pleural thickening; 4. coagulation disorders; 5. PLT < 40 x 10^9/L; 6. Severe infection; 7. Severe heart disease, arrhythmia or cardiac insufficiency; 8. Systemic disease or cancer; 9. Pregnant women; 10. Patients get involved in other clinical trials or completed the previous clinical trials within 90 days; 11. Other occasions when considered by the investigators. 

研究实施时间:

Study execute time:

From2020-01-01To 2021-02-28 

干预措施:

Interventions:

组别:

1

样本量:

180

Group:

1

Sample size:

干预措施:

内科胸腔镜下氩气刀肺减容术

干预措施代码:

Intervention:

argon knife lung volume reduction under thoracoscope

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Integrated Hospital of Traditional Chinese Medicine, Southern Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shanxi 

City:

Xi‘an 

单位(医院):

唐都医院 

单位级别:

三级甲等 

Institution
hospital:

Tang Dou Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

泉州 

Country:

China 

Province:

Fujian 

City:

Quanzhou 

单位(医院):

福建医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Fujian Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

中山 

Country:

China 

Province:

Guangdong 

City:

Zhongshan 

单位(医院):

广东医科大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Zhongshan Hospital of Guangdong Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

顺德 

Country:

China 

Province:

Guangdong 

City:

Shunde 

单位(医院):

南方医科大学顺德医院 

单位级别:

三级甲等 

Institution
hospital:

Shunde Hospital of Southern Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

沧州市 

Country:

China 

Province:

Hebei 

City:

Cangzhou 

单位(医院):

沧州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Cangzhou Central Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

烟台 

Country:

China 

Province:

Shandong 

City:

Yantai 

单位(医院):

烟台毓璜顶医院 

单位级别:

三级甲等 

Institution
hospital:

Yantai Yuhuangding hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市胸科医院 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou Chest Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Wenzhou University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

Chest CT scan

Type:

Primary indicator 

测量时间点:

术后1个月、3个月

测量方法:

胸部CT

Measure time point of outcome:

Postoperative 1 month, 3 months

Measure method:

Chest CT scan

指标中文名:

肺功能

指标类型:

次要指标 

Outcome:

Pulmonary Function

Type:

Secondary indicator 

测量时间点:

术后1个月、3个月

测量方法:

肺功能

Measure time point of outcome:

Postoperative 1 month, 3 months

Measure method:

Pulmonary Function

指标中文名:

六分钟步行距离

指标类型:

次要指标 

Outcome:

Six-minute walk

Type:

Secondary indicator 

测量时间点:

术后1个月、3个月

测量方法:

六分钟步行距离

Measure time point of outcome:

Postoperative 1 month, 3 months

Measure method:

Six-minute walk

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

blood gas analysis

Type:

Secondary indicator 

测量时间点:

术后1个月、3个月

测量方法:

血气分析

Measure time point of outcome:

Postoperative 1 month, 3 months

Measure method:

blood gas analysis

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

单臂研究,未进行分组

Randomization Procedure (please state who generates the random number sequence and by what method):

single arm with only one group

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

采用中国临床试验注册中心的临床试验原始数据共享平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Chinese Clinical Trial Registry

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-30
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