今天是:2019-06-24 星期一

内镜下黏膜剥离术(ESD)与套扎式黏膜切除术(EMR-L)治疗小于1cm的直肠神经内分泌肿瘤的随机对照临床研究
下载XML文档

注册号:

Registration number:

ChiCTR1900022524 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

内镜下黏膜剥离术(ESD)与套扎式黏膜切除术(EMR-L)治疗小于1cm的直肠神经内分泌肿瘤的随机对照临床研究 

Public title:

Endoscopic submucosal dissection (ESD) VS.endoscopic mucosal resection with a ligating device (EMR-L) for small rectal neuroendocrine tumors (NET) less than 1 cm: a randomized controlled trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

内镜下黏膜剥离术(ESD)与套扎式黏膜切除术(EMR-L)治疗小于1cm的直肠神经内分泌肿瘤的随机对照临床研究 

Scientific title:

Endoscopic submucosal dissection (ESD) VS.endoscopic mucosal resection with a ligating device (EMR-L) for small rectal neuroendocrine tumors (NET) less than 1 cm: a 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:

裴庆山 

研究负责人:

史永军 

Applicant:

Qingsha Pei 

Study leader:

Yongjun Shi 

申请注册联系人电话:

Applicant telephone:

+86 15764152065 

研究负责人电话:

Study leader's telephone:

+86 0531-68773293 

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:

peiqingshan@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

shyjxfj@sina.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:

山东省济南市经十路9677号 

研究负责人通讯地址:

山东省济南市经十路9677号 

Applicant address:

9677 Jingshi Road, Ji‘nan, Shandong 

Study leader's address:

9677 Jingshi Road, Ji’nan, Shandong 

申请注册联系人邮政编码:

Applicant postcode:

250014 

研究负责人邮政编码:

Study leader's postcode:

250014 

申请人所在单位:

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:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

LCYJ:NO.2019-037 

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:

山东大学附属省立医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shandong Provincial Hospital Affiliated to Shandong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-25 

伦理委员会联系人:

高贵得 

Contact Name of the ethic committee:

Gao Guide 

伦理委员会联系地址:

山东省济南市经五纬十路 324号 

Contact Address of the ethic committee:

324 Jingwuweishi Road, Ji'nan, Shandong 

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:

山东省立医院 

Primary sponsor:

Shandong Provincial Hospital Affiliated to Shandong University 

研究实施负责(组长)单位地址:

山东省济南市经十路9677号 

Primary sponsor's address:

9677 Jingshi Road, Ji'nan, Shandong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong

City:

Ji'nan

单位(医院):

山东省立医院

具体地址:

经十路9677号

Institution
hospital:

Shandong Provincial Hospital Affiliated to Shandong University

Address:

9677 Jingshi Road

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

神经内分泌肿瘤 

Target disease:

neuroendocrine neoplasm 

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:

其它 

Study phase:

N/A 

研究目的:

比较ESD与EMR-L两种内镜治疗方式对于小于1cm的直肠神经内分泌肿瘤的R0切除率,并发症发生率,内镜操作时间以及复发率等,评估内镜治疗方式的安全性及有效性。 

Objectives of Study:

The aims of the present study was to compare the efficacy and safety of endoscopic mucosal resection (EMR) with a ligation device and endoscopic submucosal dissection (ESD) for the small rectal neuroendocrine tumors (NET) less than 1 cm. The primary outcome was complete resection rate, and the secondary outcomes were complication rate, procedure time, and recurrence rate. 

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:

①18岁以上中国人群;②诊断明确或者内镜、EUS等检查高度怀疑为直肠神经内分泌肿瘤;③EUS提示病变局限于粘膜层或粘膜下层且病变最大直径小于1cm;④受试者愿意接受治疗并自愿签署知情同意书。 

Inclusion criteria

1. Aged older than 18 years Chinese patient; 2. Suspected rectal NET confirmed by colonoscopy or EUS; 3. The tumor was limited to mucosal or submucosal layer and less than 1 cm; 4. The patients sign the inform consent and received the treatment. 

排除标准:

①CT检查发现淋巴结转移或者远处转移;②合并恶性肿瘤等其他严重的伴随疾病无法耐受手术治疗。 

Exclusion criteria:

1. Metastasis was confirmed by preoperative examination; 2. The patient could not tolerate the treatment. 

研究实施时间:

Study execute time:

From2019-05-01To 2022-04-30 

干预措施:

Interventions:

组别:

ESD组

样本量:

35

Group:

ESD group

Sample size:

干预措施:

ESD方式切除肿瘤

干预措施代码:

Intervention:

Tumor resected by ESD

Intervention code:

组别:

EMR-L组

样本量:

35

Group:

EMR-L group

Sample size:

干预措施:

EMR-L方式切除肿瘤

干预措施代码:

Intervention:

Tumor resected by EMR-L

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

山东省立医院 

单位级别:

三甲 

Institution
hospital:

Shandong Provincial Hospital Affiliated to Shandong University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

R0切除率

指标类型:

主要指标 

Outcome:

R0 resection rate

Type:

Primary indicator 

测量时间点:

术后

测量方法:

病理评估

Measure time point of outcome:

postoperation

Measure method:

pathological assessment

指标中文名:

操作时间

指标类型:

次要指标 

Outcome:

operation time

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

计时器计时

Measure time point of outcome:

during operation

Measure method:

recorded by a timer

指标中文名:

并发症发生率

指标类型:

次要指标 

Outcome:

complication rate

Type:

Secondary indicator 

测量时间点:

术中及术后

测量方法:

记录发生次数

Measure time point of outcome:

Intraoperation and postoperation

Measure method:

the times of complication was recorded

指标中文名:

复发与转移率

指标类型:

主要指标 

Outcome:

recurrence and metastasis

Type:

Primary indicator 

测量时间点:

术后随访

测量方法:

内镜或CT

Measure time point of outcome:

the follow-up time

Measure method:

endoscopy or CT

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

直肠肿物

组织:

直肠

Sample Name:

the resected rectal tumor

Tissue:

rectum

人体标本去向

使用后保存 

说明

病理检查

Fate of sample:

Preservation after use 

Note:

pathological examination

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):

随机数字表法 (裴庆山医师:请补充说明何人使用随机数字表产生随机序列)

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

random number table

盲法:

open

Blinding:

open

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):

试验完成后共享于网络平台:中国临床试验注册中心;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):

sharing metadata and protocol 6 months after the trial complete at: 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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-15
返回列表