今天是:2019-12-12 星期四

两种经肝途径超声内镜引导下胆管引流术的系统性比较:多中心随机对照研究
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注册号:

Registration number:

ChiCTR1900020737 

最近更新日期:

Date of Last Refreshed on:

2019-11-10 

注册时间:

Date of Registration:

2019-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

两种经肝途径超声内镜引导下胆管引流术的系统性比较:多中心随机对照研究 

Public title:

Comparative Evaluation of EUS-guided hepaticogastrostomy (EUS-HGS) and EUS guided antegrade technique (EUS-AG) in patients with malignant biliary obstructive: a multicenter randomized controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

两种经肝途径超声内镜引导下胆管引流术的系统性比较:多中心随机对照研究 

Scientific title:

Comparative Evaluation of EUS-guided hepaticogastrostomy (EUS-HGS) and EUS guided antegrade technique (EUS-AG) in patients with malignant biliary obstructive: a multicenter randomized controlled trial  

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:

廖晔 

研究负责人:

郭瑾陶 

Applicant:

Liao Ye 

Study leader:

Guo Jintao 

申请注册联系人电话:

Applicant telephone:

+86 18309817351 

研究负责人电话:

Study leader's telephone:

+86 18940256654 

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:

454681608@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

guojt@sj-hospital.org 

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:

沈阳市和平区三好街36号盛京医院内镜中心 

研究负责人通讯地址:

沈阳市和平区三好街36号盛京医院内镜中心 

Applicant address:

36 Sanhao Street, Shenyang, Liaoning, China 

Study leader's address:

36 Sanhao Street, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 

Applicant's institution:

Shenjing Hospital of China 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:

2018PS525K 

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:

中国医科大学附属盛京医院医学科研与新技术伦理委员会  

Name of the ethic committee:

Medical scientific research and new technology Ethics Committee of Shengjing Hospital of China Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-22 

伦理委员会联系人:

王洪 

Contact Name of the ethic committee:

Hong Wang 

伦理委员会联系地址:

和平区三好街36号中国医科大学附属盛京医院8号楼4楼 

Contact Address of the ethic committee:

36 Sanhao Street, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 

Primary sponsor:

Shenjing Hospital of China Medical University 

研究实施负责(组长)单位地址:

沈阳市和平区三好街36号盛京医院内镜中心 

Primary sponsor's address:

36 Sanhao Street, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属盛京医院

具体地址:

和平区三好街36号盛京医院

Institution
hospital:

Shenjing Hospital of China Medical University

Address:

36 Sanhao Street, Heping District

经费或物资来源:

盛京自由研究者基金 

Source(s) of funding:

Shengjing Free Researcher Project Foundation 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过多个医学中心的随机对照试验,比较HGS与AG的技术成功率、临床缓解率、并发症发生率、住院时间及平均花费,评估两种治疗方式的安全性、有效性与经济成本。进一步阐明两种技术的优缺点,为下一步指南的制定提供最优质的证据。 

Objectives of Study:

The aim of the study is to evaluate the safety, efficiency and economic cost of EUS-HGS and EUS-AG in patients with unresectable malignant biliary obstruction by a multicenter randomized controlled trial. Which help to further clarify the advantages and disadvantages of these two IH approaches and provide the best evidence for the formulation of next guidance 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

满足以下条件的恶性胆道梗阻患者: 1) ERCP失败 ; 2) 存在肝内胆管扩张 ; 3) 低位胆道梗阻伴幽门或十二指肠梗阻,内镜无法到达壶腹部。 

Inclusion criteria

Patients with unresectable malignant biliary obstruction undergoing: 1) failed ERCP; 2) anatomical abnormalities; 3) low-level biliary obstruction and pyloric or duodenal obstruction caused by tumors 

排除标准:

具有明确内镜禁忌症的患者 

Exclusion criteria:

Patients with a clear contraindication to endoscopy 

研究实施时间:

Study execute time:

From2019-02-01To 2021-04-30 

干预措施:

Interventions:

组别:

HGS实验组

样本量:

74

Group:

HGS

Sample size:

干预措施:

EUS引导下肝胃吻合术

干预措施代码:

Intervention:

EUS-guided hepaticogastrostomy

Intervention code:

组别:

AG实验组

样本量:

74

Group:

AG group

Sample size:

干预措施:

EUS引导下顺行技术

干预措施代码:

Intervention:

EUS-guided antegrade technique

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shenjing Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

国家:

法国 

省(直辖市):

马赛 

市(区县):

 

Country:

France 

Province:

Marseille 

City:

 

单位(医院):

Paoli-Calmettes研究所 

单位级别:

 

Institution
hospital:

Institut Paoli Calmettes  

Level of the institution:

 

国家:

美国 

省(直辖市):

德克萨斯州 

市(区县):

 

Country:

America 

Province:

Texas 

City:

 

单位(医院):

德州大学安德森癌症中心 

单位级别:

 

Institution
hospital:

The University of Texas MD Anderson Cancer Center  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

血液

指标类型:

主要指标 

Outcome:

blood

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT

指标类型:

主要指标 

Outcome:

CT

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:

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 85 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):

信封法:单数患者应用EUS-AG方式进行胆道引流,双数患者应用EUS-HGS方式进行胆道引流。

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

Envelope method:patients with odd number will be treated with EUS-AG while dual-number patients be treated with the EUS-HGS.

盲法:

未说明

Blinding:

Not stated

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:

即时公开/Real time access

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):

http://www.chictr.org.cn

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

http://www.chictr.org.cn

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:

病例记录表

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-15
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