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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
四川大学华西医院 |
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Applicant's institution: |
West China Hospital, Sichuan University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Biomedical Ethics Committee of West China Hospital, Sichuan University |
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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 |
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Contact Name of the ethic committee: |
Zhao Pang |
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伦理委员会联系地址: |
四川省成都市国学巷37号 |
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Contact Address of the ethic committee: |
NO 37, Guo Xue Xiang, Chengdu, Sichuan, China |
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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 |
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Primary sponsor: |
West China Hospital, Sichuan University |
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研究实施负责(组长)单位地址: |
四川省成都市国学巷37号 |
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Primary sponsor's address: |
NO 37, Guo Xue Xiang, Chengdu, Sichuan, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
四川省科技计划 |
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Source(s) of funding: |
Sichuan Science and Technology Program |
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研究疾病: |
肝硬化 |
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Target disease: |
Liver cirrhosis |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
基础科学研究 |
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Study type: |
Basic Science |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
探讨肝硬化患者不同部位血液代谢组学差异 |
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Objectives of Study: |
To investigate metabononics disparity of blood from different sites in liver cirrhosis individuals |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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纳入标准: |
1)18~75岁; 2)确诊肝硬化; 3)接受择期TIPS手术。 |
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Inclusion criteria |
1) Aged 18 to 75 years; 2) Diagnosed with liver cirrhosis; 3) Receive elective TIPS. |
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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。 |
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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: |
从From2020-11-09至To 2025-10-31 |
征募观察对象时间: Recruiting time: |
从From2020-11-09至To 2024-10-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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 |