今天是:2021-01-18 星期一

肝硬化患者不同部位血液代谢组学的差异性研究
下载XML文档

注册号:

Registration number:

ChiCTR2000039614 

最近更新日期:

Date of Last Refreshed on:

2020-11-03 

注册时间:

Date of Registration:

2020-11-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肝硬化患者不同部位血液代谢组学的差异性研究 

Public title:

Metabononics disparity study of blood from different sites in liver cirrhosis individuals 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肝硬化TIPS术致机体内环境改变及术后不良事件风险预测的临床研究 

Scientific title:

Clinical studies of alternations of human internal environment and risk prediction of adverse events subsequent to transjugular intrahepatic portosystemic shunt in liver cirrhosis 

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:

张 林昊 

研究负责人:

童 欢 

Applicant:

Linhao Zhang 

Study leader:

Huan Tong 

申请注册联系人电话:

Applicant telephone:

+86 28 85423387 

研究负责人电话:

Study leader's telephone:

+86 28 85423387 

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:

zhanglinhao1992@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

doctortonghuan@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:

四川省成都市国学巷37号 

研究负责人通讯地址:

四川省成都市国学巷37号 

Applicant address:

NO. 37, Guo Xue Xiang, Chengdu, Sichuan, China 

Study leader's address:

NO. 37, Guo Xue Xiang, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2020-814 

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:

四川大学华西医院生物医学伦理委员会 

Name of the ethic committee:

Biomedical Ethics Committee of West China Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-10-13 

伦理委员会联系人:

庞昭 

Contact Name of the ethic committee:

Zhao Pang 

伦理委员会联系地址:

四川省成都市国学巷37号 

Contact Address of the ethic committee:

NO 37, Guo Xue Xiang, Chengdu, Sichuan, China  

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

四川省成都市国学巷37号 

Primary sponsor's address:

NO 37, Guo Xue Xiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

NO 37, Guo Xue Xiang, Chengdu, Sichuan, China

经费或物资来源:

四川省科技计划 

Source(s) of funding:

Sichuan Science and Technology Program 

研究疾病:

肝硬化 

Target disease:

Liver cirrhosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨肝硬化患者不同部位血液代谢组学差异 

Objectives of Study:

To investigate metabononics disparity of blood from different sites in liver cirrhosis individuals 

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)18~75岁; 2)确诊肝硬化; 3)接受择期TIPS手术。 

Inclusion criteria

1) Aged 18 to 75 years; 2) Diagnosed with liver cirrhosis; 3) Receive elective TIPS. 

排除标准:

1)既往曾行TIPS或者外科分流手术; 2)肝性脑病既往病史,或纳入时诊断肝性脑病; 3)肝性脊髓病及其它神经精神疾病; 4)术前4周内使用营养制剂、抗生素或乳果糖; 5)消化道出血、自发性腹膜炎、肝肾综合征、肝肺综合征等肝硬化并发症未控制或稳定<1周; 6)心脏、肺、肾、脑等重大脏器功能不全; 7)视力受损影响阅读; 8)极低文化程度,不能阅读及书写简单的字词; 9)来自高海拔地区(>2500米 ); 10)孕妇及哺乳期妇女; 11)肝功能Child 评分超过12分, 转氨酶超过正常上限5倍 : 12)淤胆性肝病(原发性胆汁性胆管炎、原发性硬化性胆管炎及肝外胆管梗阻等); 13)合并恶性肿瘤; 14)门脉海绵样变性。 

Exclusion criteria:

1) Previous treatments with TIPS or surgical shunt; 2) History of hepatic encephalopathy or hepatic encephalopathy diagnosed at enrollment; 3) Hepatic myelopathy or other neuropsychological disorders; 4) Prescribed with medical enternal or parenternal nutrition, antibiotics, or lactulose within 4 weeks before enrollment; 5) Gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome or hepatopulmonary syndrome is uncontrolled or stable less than 1 week; 6) Vital organ insufficiency (heart, lung, kidney, brain, etc.); 7) Incompetent of reading due to compromised vision; 8) Poor literacy to recognize and comprehend simple words; 9) Residency in high altitudes (higher than 2500 meters above the sea level); 10) In pregnancy or lactation; 11) Child-Pugh score exceeds 12 points or aminotransferase elevations exceeds five times of upper limits of normal; 12) Cholestatic diseases (primary biliary cirrhosis, primary sclerosing cholangitis, extrahepatic bile duct obstruction, etc.) 13) Presence of malignancy; 14) Portal cavernoma. 

研究实施时间:

Study execute time:

From2020-11-09To 2025-10-31 

征募观察对象时间:

Recruiting time:

From2020-11-09To 2024-10-31 

干预措施:

Interventions:

组别:

肝硬化

样本量:

20

Group:

Liver cirrhosis

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

大学附属医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

University hospital 

测量指标:

Outcomes:

指标中文名:

代谢组学

指标类型:

主要指标 

Outcome:

Metabonomics

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 18 years
最大 Max age 75 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):

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

N/A

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):

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):

如对原始数据有合理需求者,可通过与项目负责人联系

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

Contact with PI if reasonable request on raw data is met.

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:

有专门的病例记录表记录数据,通过Epidata和SPSS管理数据。

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

CRF is used to record data, Epidata and SPPS are used to manage data.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-03
返回列表