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食管早癌术前内镜下钛夹标记的临床研究
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注册号:

Registration number:

ChiCTR-INR-17010949 

最近更新日期:

Date of Last Refreshed on:

2017-03-22 

注册时间:

Date of Registration:

2017-03-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

食管早癌术前内镜下钛夹标记的临床研究 

Public title:

Clinical evaluation of preoperative endoscopic marking with titanium clips in patients with early-stage esophageal cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

食管早癌术前内镜下钛夹标记的临床研 

Scientific title:

Clinical evaluation of preoperative endoscopic marking with titanium clips in patients with early-stage esophageal cancer 

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:

谈磊 

研究负责人:

谈磊 

Applicant:

Lei Tan 

Study leader:

Lei Tan 

申请注册联系人电话:

Applicant telephone:

+86 0538-6298489 

研究负责人电话:

Study leader's telephone:

+86 0538-6298489 

申请注册联系人传真 :

Applicant Fax:

+86 0538-6298525 

研究负责人传真:

Study leader's fax:

+86 0538-6298525 

申请注册联系人电子邮件:

Applicant E-mail:

tanlei_xw@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tanlei_xw@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:

山东省泰安市龙潭路29号泰安市中心医院胸外科 

研究负责人通讯地址:

山东省泰安市龙潭路29号泰安市中心医院胸外科 

Applicant address:

Department of thoracic surgery, Tai'an Central Hospital, 29 Longtan Road, Tai'an, Shandong, China 

Study leader's address:

Department of thoracic surgery, Tai'an Central Hospital, 29 Longtan Road, Tai'an, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

271000 

研究负责人邮政编码:

Study leader's postcode:

271000 

申请人所在单位:

泰安市中心医院 

Applicant's institution:

Tai'an Central Hospital  

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:

2017-001 

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:

泰安市中心医院医学伦理委员会 

Name of the ethic committee:

Ethic committee of Tai'an Central Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-02-09 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

泰安市中心医院 

Primary sponsor:

Tai'an Central Hospital  

研究实施负责(组长)单位地址:

山东省泰安市龙潭路29号 

Primary sponsor's address:

29 Longtan Road, Tai'an, Shandong, 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):

山东

市(区县):

泰安

Country:

China

Province:

Shandong

City:

Tai'an

单位(医院):

泰安市中心医院

具体地址:

山东省泰安市龙潭路29号

Institution
hospital:

Tai'an Central Hospital

Address:

29 Longtan Road, Tai'an, Shandong, China

经费或物资来源:

自筹 

Source(s) of funding:

NO 

研究疾病:

食管早癌 

Target disease:

early-stage esophageal cancer 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探讨早期食管癌术前内镜下钛夹标记在外科手术中的应用价值。  

Objectives of Study:

To explore the application value of preoperative endoscopic marking with titanium clips for early-stage esophageal cancer.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.经胃镜,食道超声内镜检查及病理证实食管癌分期为T1患者2.所有实验组患者知情并签署知情同意书,经伦理委员会审核通过。 

Inclusion criteria

1. patients in early-stage squamous cell carcinoma of esophagus or severe dysplasia is gastroscopically detected and pathologically confirmed in our hospital; 2. All patients have had signed the informed consent form and the study was approved by the Ethics Committee. 

排除标准:

1.无法接受外科手术者 2.术后病理证实为非T1患者 3.颈段食管癌患者 

Exclusion criteria:

1. unable to undergo surgery; 2. pathologically confirmed non T1 patients; 3. patients with cervical esophageal carcinoma. 

研究实施时间:

Study execute time:

From2017-05-01To 2018-12-01 

征募观察对象时间:

Recruiting time:

From2017-05-01To 2018-05-01 

干预措施:

Interventions:

组别:

实验组

样本量:

15

Group:

experimental group

Sample size:

干预措施:

术前内镜下钛夹标记

干预措施代码:

Intervention:

preoperative endoscopic marking with titanium clips

Intervention code:

组别:

对照

样本量:

15

Group:

Control

Sample size:

干预措施:

常规

干预措施代码:

Intervention:

Routine approach

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

泰安 

Country:

China 

Province:

Shandong 

City:

Tai'an 

单位(医院):

泰安市中心医院 

单位级别:

三甲 

Institution
hospital:

Tai'an Central Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术中肿瘤定位

指标类型:

主要指标 

Outcome:

Intraoperative tumor localization

Type:

Primary indicator 

测量时间点:

手术中

测量方法:

手术开始首先打开纵隔胸膜后由手术者触摸食管探查肿瘤或钛夹的位置

Measure time point of outcome:

Intraoperative

Measure method:

After the mediastinal pleura was opened, the location of the tumor or the clips was detected by palpation.

指标中文名:

食管切除后定位

指标类型:

主要指标 

Outcome:

Post-esophagectomy tumor localization

Type:

Primary indicator 

测量时间点:

手术中

测量方法:

手术当中切断食管后再次由术者管腔内探查肿瘤或钛夹的位置

Measure time point of outcome:

Intraoperative

Measure method:

After the esophagus was transected, the location of the tumor and clips was again inspected by intraluminal palpation.

指标中文名:

术后病理确诊

指标类型:

主要指标 

Outcome:

Postoperative pathological diagnosis

Type:

Primary indicator 

测量时间点:

术后

测量方法:

病理确诊

Measure time point of outcome:

Postoperative

Measure method:

pathological diagnosis

指标中文名:

上切缘阴性

指标类型:

主要指标 

Outcome:

Negative upper surgical margin

Type:

Primary indicator 

测量时间点:

术后

测量方法:

病理诊断

Measure time point of outcome:

Postoperative

Measure method:

pathological diagnosis

指标中文名:

手术方式改变

指标类型:

主要指标 

Outcome:

Change of surgical approaches

Type:

Primary indicator 

测量时间点:

手术中

测量方法:

Measure time point of outcome:

Postoperative

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

肿瘤

组织:

食管

Sample Name:

Tumor

Tissue:

Esophagus

人体标本去向

使用后保存 

说明

病理科保存

Fate of sample:

Preservation after use 

Note:

Pathology preservation

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):

由胸外科研究生负责根据诊顺序的单双号来产生随机序列

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

A graduate student is responsible for generating the random sequence ,According to the medical order and odd number

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

试验完成后及时公开原始数据,数据上传到ResMan临床试验公共管理平台

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

Test is completed in a timely manner and open the original data, the data uploaded to the ResMan clinical trials of public management platform

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:

临床试验公共管理平台

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

Research Manager, ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-03-22
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