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The Medium-and Long-Term Clinical Research of Radiofrequency Ablation Combined With Percutaneous Vertebroplasty in Spine Metastases
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注册号:

Registration number:

ChiCTR-INR-16010135 

最近更新日期:

Date of Last Refreshed on:

2016-12-12 

注册时间:

Date of Registration:

2016-12-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

射频消融联合椎体成形术治疗脊柱转移瘤的中远期临床观察 

Public title:

The Medium-and Long-Term Clinical Research of Radiofrequency Ablation Combined With Percutaneous Vertebroplasty in Spine Metastases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

射频消融联合椎体成形术治疗脊柱转移瘤的中远期临床观察 

Scientific title:

The Medium-and Long-Term Clinical Research of Radiofrequency Ablation Combined With Percutaneous Vertebroplasty in Spine Metastases 

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:

许宋锋 

研究负责人:

于胜吉 

Applicant:

Songfeng Xu 

Study leader:

Shengji Yu 

申请注册联系人电话:

Applicant telephone:

+86 13581809738 

研究负责人电话:

Study leader's telephone:

+86 18811050322 

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:

xusongfeng@yeah.net 

研究负责人电子邮件:

Study leader's E-mail:

shengjiyu@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cicams.ac.cn 

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:

北京市朝阳区潘家园南里17号 

研究负责人通讯地址:

北京市朝阳区潘家园南里17号 

Applicant address:

17 South Panjiayuan Street, Chaoyang District, Beijing, China 

Study leader's address:

17 South Panjiayuan Street, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100021 

研究负责人邮政编码:

Study leader's postcode:

100021 

申请人所在单位:

国家癌症中心 中国医学科学院 北京协和医学院肿瘤医院骨科 

Applicant's institution:

Department of Orthopedics, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College, Beijing 

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:

NCC2016 YL-01 

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:

中国医学科学院肿瘤医院伦理委员会 

Name of the ethic committee:

Ethics committee of National Cancer Center&Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College, Beijing 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-10-09 

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:

国家癌症中心 中国医学科学院 北京协和医学院肿瘤医院 

Primary sponsor:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College 

研究实施负责(组长)单位地址:

北京市朝阳区潘家园南里17号 

Primary sponsor's address:

17 South Panjiayuan Street, Chaoyang District, Beijing, 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):

北京市

市(区县):

朝阳区

Country:

China

Province:

Beijing

City:

ChaoYang District

单位(医院):

国家癌症中心 中国医学科学院 北京协和医学院肿瘤医院

具体地址:

北京市朝阳区潘家园南里17号

Institution
hospital:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College

Address:

17 South Panjiayuan Street, Chaoyang District, Beijing, China

国家:

中国

省(直辖市):

上海

市(区县):

卢湾区

Country:

China

Province:

Shanghai

City:

LuWan District

单位(医院):

上海交通大学医学院瑞金医院

具体地址:

上海市卢湾区瑞金二路197号

Institution
hospital:

RuiJin Hospital, ShangHai JiaoTao Universtiy, School of Medicine

Address:

197 Second Ruijin Road, Shanghai

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

GuangZhou

单位(医院):

中山大学附属第一医院

具体地址:

广州市越秀区中山二路58号

Institution
hospital:

The first affliliated hospital, Sun Ya-sen University

Address:

58 Second Zhongshan Road, Guangzhou, Guangdong, China

经费或物资来源:

中国癌症基金会 北京希望马拉松专项 基金 

Source(s) of funding:

Beijing Hope Marathon Special Fund, China Cancer Foundation 

研究疾病:

脊柱转移瘤 

Target disease:

Spine Metastases 

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:

应用射频消融联合椎体成形术与单纯椎体成形术相比较治疗脊柱转移瘤,大样本多中心前瞻性开展研究,观察此治疗体系的镇痛及肿瘤局部控制率,明确相关适应证与禁忌证,规范临床应用并推广。 

Objectives of Study:

We carry out this research on multicenter prospective observation on the effect of analgesia and tumor local control rate with the application of radiofrequency ablation combined with vertebroplasty compared to vertebroplasty only for spinal metastases, to make it clear that the indications and contraindications, to standardize the clinical application and promotion. 

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:

①符合诊断标准;②轻中度以上疼痛(VAS评分≥3分);③年龄超过18岁;④椎体后缘骨皮质连续性完整;⑤预期生存期超过3个月;⑥签署知情同意书。 

Inclusion criteria

1. Meet the diagnostic critrea; 2. Moderate pain(VAS>3); 3. Aged over 18 years; 4. The vertebral bone cortical continuity was intact; 5. The expected survival is more than 3 months; 6. Signing informed consent. 

排除标准:

①无法纠正的出血倾向或凝血功能障碍;②存在全身感染或穿刺部位感染;③弥漫性非局灶性背痛;④神经根性疼痛;⑤对PMMA过敏;⑥症状表现为轻度疼痛,药物治疗即可明显改善;⑦全身情况差、严重心肺疾患难以耐受手术;⑧月经期或妊娠期。 

Exclusion criteria:

1. Inable to correct the bleeding tendency or coagulopathy; 2. There are systemic infection or puncture site infection; 3. the diffuse non focal pain; 4. the radicular pain; 5. Be allergy to the PMMA; 6. symptoms of mild pain, drug treatment can be significantly improved; 7. the general condition is poor, serious heart and lung diseases difficult to tolerate surgery; 8. the menstrual period or pregnancy. 

研究实施时间:

Study execute time:

From2016-12-12To 2021-09-01 

干预措施:

Interventions:

组别:

A

样本量:

105

Group:

A

Sample size:

干预措施:

射频消融联合椎体成形

干预措施代码:

Intervention:

Radiofrequency Ablation Combined With Percutaneous Vertebroplasty

Intervention code:

组别:

B

样本量:

105

Group:

B

Sample size:

干预措施:

椎体成形

干预措施代码:

Intervention:

Percutaneous Vertebroplasty

Intervention code:

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):

朝阳区 

Country:

China 

Province:

Beijing 

City:

ChaoYang District 

单位(医院):

国家癌症中心 中国医学科学院 北京协和医学院肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

卢湾区 

Country:

China 

Province:

Shanghai 

City:

LuWan District 

单位(医院):

上海交通大学医学院瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

RuiJin Hospital, ShangHai JiaoTao Universtiy, School of Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

GuangZhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The first affliliated hospital, Sun Ya-sen University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分

指标类型:

主要指标 

Outcome:

Visual analogue scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤局部控制

指标类型:

次要指标 

Outcome:

tumor local control

Type:

Secondary 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):

SAS统计分析系统,生成随机数,组成随机编码表

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

SAS statistical analysis system, generate random numbers, composed of random coding table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

原始数据将在研究结束时在本注册平台公开

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

The original data will be disclosed at the end of the study in this Registry Platform

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:

数据以电子版的形式保存在专门的电脑中,此电脑不做他用,并设有密码。采用Excel表格记录并保存。

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

Data in the form of electronic version would be stored in a dedicated computer and with a password. Record would be saved with Excel form.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-12-12
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