今天是:2019-12-10 星期二

张月宁医师:该研究的伦理审批文件未上传,请尽快上传。 测量肝静脉压力梯度选择不同肝静脉的差异及其准确性研究
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注册号:

Registration number:

ChiCTR1900024776 

最近更新日期:

Date of Last Refreshed on:

2019-07-27 

注册时间:

Date of Registration:

2019-07-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

张月宁医师:该研究的伦理审批文件未上传,请尽快上传。 测量肝静脉压力梯度选择不同肝静脉的差异及其准确性研究 

Public title:

A study for the difference and accuracy among different hepatic veins for measuring hepatic venous pressure gradient 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

测量肝静脉压力梯度选择不同肝静脉的差异及其准确性研究 

Scientific title:

A study for the difference and accuracy among different hepatic veins for measuring hepatic venous pressure gradient 

研究课题代号(代码):

Study subject ID:

YNKTTS20180101 

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:

张月宁 

研究负责人:

张月宁 

Applicant:

Zhang Yuening 

Study leader:

Zhang Yuening 

申请注册联系人电话:

Applicant telephone:

+86 13366038659 

研究负责人电话:

Study leader's telephone:

+86 13366038659 

申请注册联系人传真 :

Applicant Fax:

+86 010 83997155 

研究负责人传真:

Study leader's fax:

+86 010 83997155 

申请注册联系人电子邮件:

Applicant E-mail:

zhangyn-ty@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyn-ty@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.bjyah.com/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.bjyah.com/ 

申请注册联系人通讯地址:

北京市丰台区右安门外西头条8号北京佑安医院肝病消化中心 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 北京佑安医院肝病消化中心 

Applicant address:

8 Xitoutiao, You'anmenwai, Fengtai District, Beijing 

Study leader's address:

8 Xitoutiao, You'anmenwai, Fengtai District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100069 

研究负责人邮政编码:

Study leader's postcode:

100069 

申请人所在单位:

首都医科大学附属北京佑安医院 

Applicant's institution:

Beijing You'an Hospital, Capital 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:

京佑科伦字[2019]018号 

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:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethics Committee, Beijing You'an Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-17 

伦理委员会联系人:

盛艾娟 

Contact Name of the ethic committee:

Sheng Aijuan 

伦理委员会联系地址:

首都医科大学附属北京佑安医院 

Contact Address of the ethic committee:

Beijing You'an Hospital, Capital Medical University 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010 83997028 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yakych@163.com 

研究实施负责(组长)单位:

首都医科大学附属北京佑安医院 

Primary sponsor:

Beijing You'an Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条8号 

Primary sponsor's address:

8 Xitoutiao, You'anmenwai, Fengtai District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都医科大学附属北京佑安医院

具体地址:

丰台区右安门外西头条8号

Institution
hospital:

Beijing You'an Hospital, Capital Medical University

Address:

8 Xitoutiao, You'anmenwai, Fengtai District

经费或物资来源:

中国初级卫生保健基金会-佑安肝病艾滋病基金 

Source(s) of funding:

China Primary Health Care Foundation?-?Youan Foundation of Liver Disease and AIDS 

研究疾病:

肝硬化 

Target disease:

Cirrosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

寻找HVPG测量时的最佳选择静脉及方法。 

Objectives of Study:

Finding the best choice of vein and method for HVPG measurement. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

明确诊断的肝硬化(代偿或失代偿期,依据2015年《慢性乙型肝炎防治指南》);16-65岁、性别不限;拟进行TIPS或可以进行直接门静脉压力测定的外科手术。签署知情同意书。 

Inclusion criteria

Diagnosed Cirrhosis, 16-65, M or F, undergoing HVPG. 

排除标准:

肝后性/肝前性门静脉高压症;相关血管血栓或畸形;布加综合征;严重心肺肾疾病;严重出凝血障碍;肝功能衰竭;恶性肿瘤;体重指数大于35kg/m2;孕妇。 

Exclusion criteria:

severe diseases of heart, kidney, lung, liver failure, malignant carcinoma, pregnant, IBM>35kg/m2. 

研究实施时间:

Study execute time:

From2018-07-01To 2020-06-30 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

门静脉压力直接测量(测量导管送至门静脉,连接压力传感器)。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Direct measurement of portal vein pressure (measurement catheter sent to portal vein, connected with pressure sensor).

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

间接测量方法(肝静脉压力梯度测定)。

Index test:

HVPG measurement.

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

肝硬化患者

例数:

Sample size:

48

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients diagnosed with cirrhosis.

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三甲 

Institution
hospital:

Beijing You'an Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肝静脉压力梯度

指标类型:

主要指标 

Outcome:

HVPG

Type:

Primary indicator 

测量时间点:

-

测量方法:

经颈静脉

Measure time point of outcome:

-

Measure method:

transjugular

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary 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:

组织:

-

Sample Name:

NA

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 16 years
最大 Max age 65 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):

未使用

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

Not used

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):

ResMan, http://www.medresman.org/

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

ResMan, http://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:

Case Record Form, CRF

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-27
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