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阻抗基线与胃食管反流病食管外症状的相关性研究
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注册号:

Registration number:

ChiCTR1900021476 

最近更新日期:

Date of Last Refreshed on:

2019-02-22 

注册时间:

Date of Registration:

2019-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阻抗基线与胃食管反流病食管外症状的相关性研究 

Public title:

The correlation between impedance baseline and extra-esophgeal manifestations in GERD 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

阻抗基线在具有食管外表现的GERD相关研究 

Scientific title:

The correlation between impedance baseline and extra-esophgeal manifestations in GERD 

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:

黄莲 

研究负责人:

黄莲 

Applicant:

Lian Huang 

Study leader:

Lian Huang 

申请注册联系人电话:

Applicant telephone:

+86 19942331857 

研究负责人电话:

Study leader's telephone:

+86 19942331857 

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:

hl123h@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hl123h@126.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:

重庆市渝中区七星岗金汤街山城巷85号(重医附二院学生住宿) 

研究负责人通讯地址:

重庆市渝中区七星岗金汤街山城巷85号(重医附二院学生住宿) 

Applicant address:

85 Shancheng Lane, Jintang Street, Qixinggang, Yuzhong District, Chongqing, China 

Study leader's address:

85 Shancheng Lane, Jintang Street, Qixinggang, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

重庆医科大学 

Applicant's institution:

Chongqing 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:

2018-23 

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:

重庆医科大学附属第二医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-15 

伦理委员会联系人:

吴明珍 

Contact Name of the ethic committee:

Mingzhen Wu 

伦理委员会联系地址:

重庆市渝中区临江路76号 

Contact Address of the ethic committee:

76 Linjiang Road, Yuzhong District, Chongqing, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023 63603378 

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:

重庆医科大学附属第二医院 

Primary sponsor:

the Second Affiliated Hospital of Chongqing Medical University  

研究实施负责(组长)单位地址:

重庆市渝中区临江路76号 

Primary sponsor's address:

76 Linjiang Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

Yuzhong District

单位(医院):

重庆医科大学附属第二医院

具体地址:

重庆市渝中区临江路76号

Institution
hospital:

the Second Affiliated Hospital of Chongqing Medical University

Address:

76 Linjiang Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

胃食管反流病 

Target disease:

Gastroesophageal Reflux Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探讨食管24小时阻抗监测中,各通道阻抗基线的变化是否与胃食管反流病的食管外症状相关。 

Objectives of Study:

To explore whether the impedance baseline of each channel during 24-hour esophageal impedance monitoring are associated with extra-esophgeal manifestations in GERD. 

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)2016-1-1至2018-12-31于重庆医科大学附属第二院就诊的具有食管内和(或)外症状可疑GERD症状的患者; 2)有意愿行24h-ph阻抗监测及完善问卷调查; 3)根据最新2018年里昂共识诊断GERD患者。 

Inclusion criteria

1)Patients who have suspected symptoms of GERD go to the Second Affiliated Hospital of Chongqing Medical University in 1 January 2016 to 31 December 2016. 2)Patients are willing to perform 24h-ph impedance monitoring and complete GerdQ. 3)Patients are Diagnosed to GERD according to the latest 2018 Lyon consensus. 

排除标准:

1. 有Zollinger-Ellison综合症、贲门失弛缓、食道痉挛、食管狭窄及其他食管病变、手术患者; 2. 重大慢性疾病病史、神经系统疾病; 3. 有恶性肿瘤病史; 4. 不能配合完成试验者,如精神疾病、语言理解障碍或不能耐受检查等; 5. 1周内有服用抑酸药、影响胃肠动力药物,包括中药、保健品及食物等; 6. 伴有明显焦虑症状(汉密尔顿焦虑量表,HAMA>14); 7. 近期有服用改善焦虑、失眠等镇静药物、抗抑郁药物等; 8. 年龄小于18周岁; 9. 处于孕期或哺乳期。  

Exclusion criteria:

1. With Zollinger-Ellison syndrome;Esophageal achalasia; Esophageal spasm; Esophagostenosis and other esophagus disease or esophageal surgery; 2. With a history of chronic disease,such as asthma or neurological disease; 3. With a history of malignancy; 4. Can not complete the study for any reason, such as language comprehension disorders, mental illness or can not tolerate the test; 5. With history of taking antiacid drugs or prokinetic agent a week before the test; 6. With anxiety symptoms(HAMA>14); 7. With a history of taking the medicine to relieve anxiety symptom,insomnias recently; 8. Under 18 years old; 9. In pregnancy and lactation.  

研究实施时间:

Study execute time:

From2018-02-25To 2019-07-01 

征募观察对象时间:

Recruiting time:

From2019-02-25To 2019-07-01 

干预措施:

Interventions:

组别:

Case series

样本量:

200

Group:

Case series

Sample size:

干预措施:

24小时阻抗监测

干预措施代码:

Intervention:

24-hour esophageal impedance monitoring

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong District 

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

阻抗基线

指标类型:

主要指标 

Outcome:

Impedance-baseline

Type:

Primary indicator 

测量时间点:

测量方法:

24小时阻抗监测

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

N/A

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

N/A

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):

原始数据于试验结束后6个月以内采用ResMan临床试验公共管理平台向公众开放查询,网址:www.medresman.org.

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

The raw data will be open to the public with ResMan in the 6 months after clinical trials finished,Website: www.medresman.org.

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:

所有数据录入Excel表格中

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

All of the data will be kept in several Excel forms.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-22
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