今天是:2019-07-21 星期日

胆道支架置入术后患者院内感染率情况研究
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注册号:

Registration number:

ChiCTR1900024102 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胆道支架置入术后患者院内感染率情况研究 

Public title:

Study for the nosocomial infection rate of therapy for malignant biliary obstruction by biliary stent loaded with radioactive 125I seeds versus conventional biliary stent 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胆道支架置入术后患者院内感染率情况研究 

Scientific title:

The nosocomial infection rate of therapy for malignant biliary obstruction by biliary stent loaded  

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:

董艳超 

研究负责人:

牛洪涛 

Applicant:

Yanchao Dong 

Study leader:

Hongtao Niu 

申请注册联系人电话:

Applicant telephone:

+86 13315653806 

研究负责人电话:

Study leader's telephone:

+86 18703352928 

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:

dyc_hometown@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

niuht2004@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:

河北省秦皇岛市海港区文化路258号 

研究负责人通讯地址:

河北省秦皇岛市海港区文化路258号 

Applicant address:

258 Wenhua Road, Qinhuangdao, Hebei, China 

Study leader's address:

258 Wenhua Road, Qinhuangdao, Hebei, 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:

秦皇岛市第一医院 

Applicant's institution:

Qinhuangdao Municipal 1st Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

秦皇岛市第一医院 

Primary sponsor:

Qinhuangdao Municipal 1st Hospital 

研究实施负责(组长)单位地址:

河北省秦皇岛市海港区文化路258号 

Primary sponsor's address:

258 Wenhua Road, Qinhuangdao, Hebei, 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):

河北

市(区县):

秦皇岛

Country:

China

Province:

Hebei

City:

Qinhuangdao

单位(医院):

秦皇岛市第一医院

具体地址:

河北省秦皇岛市海港区文化路258号

Institution
hospital:

Qinhuangdao Municipal No. 1 Hospital

Address:

258 Wenhua Road, Qinhuangdao, Hebei, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

恶性胆道梗阻 

Target disease:

malignant biliary obstruction 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

为了探讨恶性胆道梗阻患者胆道支架置入术后院内感染情况。 

Objectives of Study:

To explore which biliary stent implantation has a higher nosocomial infection rate, biliary stent loaded with radioactive 125I seeds (radioactive biliary stent, RBS) or conventional biliary stent (CBS). To preliminary discuss the causes of postoperative infection. In a final note, the results would provide clinical evidence for preventing postoperative infection. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

通过临床症状、体征及相关辅助检查,明确诊断为MOJ的患者,并且梗阻部位位于胆总管中段(Bismuth-Corlette I型及更低位的胆道梗阻);既往未接受过任何外科手术、介入手术及ERCP等检查术;术前未存在明确的胆道感染及其他感染情况(无发热,白细胞不超过10×109/L,中性粒细胞);术前未以任何形式应用过抗生素。 

Inclusion criteria

Through clinical symptoms, signs and related auxiliary examinations, patients diagnosed as MBO are clearly. And obstruction site locates in the middle and low level of the bile duct (Bismuth-Corlette I and lower biliary obstruction). They have not undergone any surgical, interventional treatment and ERCP examination. There was no clear biliary infection and other infections before operation (no fever, white blood cells (WBC) counts are not exceeding 9x10^9 per unit, the percentage of neutrophils are not exceeding 70%). Antibiotics were not used in any form before surgery. 

排除标准:

术后1周内具有典型发热症状,体温较基础体温上升1℃;术后1周内复查血分析显示白细胞超过10×109/L,中性粒细胞百分比超过75%;术后血培养出细菌;术后胆红素较前无减低反而上升。 

Exclusion criteria:

After surgery, there are typical fever symptoms within 1 week, and the body temperature rises by 1 degree C from the basic body temperature, and fever continues to occur for 3 days. The blood analysis within 1 week after surgery shows that the WBC counts exceed 10x10^9 per unit, and the percentage of neutrophils exceed 75%. Blood culture has bacteria. And the bilirubin doesnt decrease but increased. 

研究实施时间:

Study execute time:

From2019-07-01To 2019-12-31 

干预措施:

Interventions:

组别:

Group 1

样本量:

20

Group:

Group 1

Sample size:

干预措施:

胆道支架携125I粒子,具有放射性

干预措施代码:

Intervention:

biliary stent loaded with radioactive 125I seeds (radioactive biliary stent, RBS)

Intervention code:

组别:

Group 2

样本量:

60

Group:

Group 2

Sample size:

干预措施:

传统胆道支架植入术

干预措施代码:

Intervention:

Conventional biliary stent loading

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

秦皇岛 

Country:

China 

Province:

Hebei 

City:

Qinhuangdao 

单位(医院):

秦皇岛市第一医院 

单位级别:

三甲医院 

Institution
hospital:

Qinhuangdao Municipal No. 1 Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

院内感染率

指标类型:

主要指标 

Outcome:

The nosocomial infection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病原菌培养及鉴定

指标类型:

次要指标 

Outcome:

Pathogenic culture and identification

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Biood

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 40 years
最大 Max age 90 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):

应用网站公布数据,2019-12-01, www.qhdsdyyy.com

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

web-based public database, 2019-12-01, www.qhdsdyyy.com

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:

病历记录表

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:

有/Yes

注册人:

Name of Registration:

 2019-06-25
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