Today is 2020-07-15

Microwave ablation versus radiofrequency ablation for perivascular hepatocellular carcinoma
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注册号:

Registration number:

ChiCTR2000028725 

最近更新日期:

Date of Last Refreshed on:

2020-01-01 

注册时间:

Date of Registration:

2020-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

对比微波消融和射频消融治疗血管周围肝癌的有效性和安全性 

Public title:

Microwave ablation versus radiofrequency ablation for perivascular hepatocellular carcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

对比微波消融和射频消融治疗血管周围肝癌的有效性和安全性 

Scientific title:

Microwave ablation versus radiofrequency ablation for perivascular hepatocellular carcinoma 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81570551; 81770607),山东省重点研究项目(2016GSF201008) 

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:

冯跃民 

研究负责人:

冯跃民 

Applicant:

Yuemin Feng 

Study leader:

Yuemin Feng 

申请注册联系人电话:

Applicant telephone:

+86 17865137793 

研究负责人电话:

Study leader's telephone:

+86 17865137793 

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:

sdyueminfeng@163.com 

研究负责人电子邮件:

Study leader's E-mail:

sdyueminfeng@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:

山东省济南市经五路324号 

研究负责人通讯地址:

山东省济南市经五路324号 

Applicant address:

324 Jingwu Road, Ji'nan, Shandong, China 

Study leader's address:

324 Jingwu Road, Ji'nan, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

250021 

研究负责人邮政编码:

Study leader's postcode:

250021 

申请人所在单位:

山东大学附属山东省立医院 

Applicant's institution:

Shandong Provincial Hospital Affiliated to Shandong University 

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:

朱强 

Primary sponsor:

Qiang Zhu 

研究实施负责(组长)单位地址:

山东省济南市经五路324号 

Primary sponsor's address:

324 Jingwu Road, Ji'nan, Shandong, 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):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东大学附属山东省立医院

具体地址:

山东省济南市经五路324号

Institution
hospital:

Shandong Provincial Hospital Afiliated to Shandong University

Address:

324 Jingwu Road, Ji'nan

经费或物资来源:

国家自然科学基金(81570551; 81770607),山东省重点研究项目(2016GSF201008) 

Source(s) of funding:

the National Natural Science Foundation of China (81570551; 81770607) and Key Research Project of Shandong Province (2016GSF201008) 

研究疾病:

肝细胞癌 

Target disease:

hepatocellular carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

比较微波消融和射频消融治疗血管周围肝癌的有效性和安全性 

Objectives of Study:

The aim of this study was to compare the efficacy and safety of Microwave ablation (MWA) and radiofrequency ablation (RFA) as the first-line treatment for patients with perivascular HCC 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1) 年龄大于18岁; 2) 不多于3个肝癌结节,最大结节不大于5cm; 3) 肝功能Child-Pugh 分级A或B.  

Inclusion criteria

1. aged older than 18 years; 2. up to 3 tumor nodules with each nodule <=5 cm; 3. Child-Pugh class A or B.  

排除标准:

患者在诊断肝癌时合并肝外转移或其他严重合并症,如其他恶性肿瘤,心肺功能不全或肾脏功能不全 

Exclusion criteria:

Patients were excluded if they had extra-hepatic metastasis at HCC diagnosis and/or other significant comorbidity such as other malignancies, cardiopulmonary compromise or renal failure.  

研究实施时间:

Study execute time:

From2020-01-15To 2020-03-15 

干预措施:

Interventions:

组别:

1

样本量:

100

Group:

1

Sample size:

干预措施:

MWA

干预措施代码:

Intervention:

MWA

Intervention code:

组别:

2

样本量:

200

Group:

2

Sample size:

干预措施:

RFA

干预措施代码:

Intervention:

RFA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

山东大学附属山东省立医院 

单位级别:

三甲医院 

Institution
hospital:

Shandong Provincial Hospital Afiliated to Shandong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总生存率

指标类型:

主要指标 

Outcome:

overall survival

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 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

不适用

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

not applicable

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

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):

请联系课题负责人获取原始数据

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

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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:

数据采集自患者住院病历,使用电子表格对数据进行管理

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

Data collected from patient hospital records.Data is managed using a spreadsheet.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-01
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