Today is 2019-12-14

Preoperative endoscopic evaluation of the diagnostic value of laterally spreading tumor (LST): a multicenter, prospective, observational clinical trial
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注册号:

Registration number:

ChiCTR1900027595 

最近更新日期:

Date of Last Refreshed on:

2019-11-20 

注册时间:

Date of Registration:

2019-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术前内镜评估大肠侧向发育型肿瘤(LST)诊断价值的临床研究:一项多中心、前瞻性、观察性临床试验 

Public title:

Preoperative endoscopic evaluation of the diagnostic value of laterally spreading tumor (LST): a multicenter, prospective, observational clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术前内镜评估大肠侧向发育型肿瘤(LST)诊断价值的临床研究 

Scientific title:

Preoperative endoscopic evaluation of the diagnostic value of laterally spreading tumor (LST)  

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:

吴保平 

研究负责人:

吴保平 

Applicant:

Baoping Wu 

Study leader:

Baoping Wu 

申请注册联系人电话:

Applicant telephone:

+86 13556197081 

研究负责人电话:

Study leader's telephone:

+86 13556197081 

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:

930213969@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

bpwu@263.net 

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:

广东省广州市广州大道北1838号 

研究负责人通讯地址:

广东省广州市广州大道北1838号 

Applicant address:

1838 North Guangzhou Avenue, Guangzhou, Guangdong, China 

Study leader's address:

1838 North Guangzhou Avenue, Guangzhou, Guangdong, 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:

南方医科大学南方医院 

Applicant's institution:

Nanfang Hospital of Southern 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:

NFEC-2017-014 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Nanfang Hospital of Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-06-13 

伦理委员会联系人:

张训 

Contact Name of the ethic committee:

Xun Zhang 

伦理委员会联系地址:

广东省广州市广州大道北1838号南方医科大学南方医院 

Contact Address of the ethic committee:

Nanfang Hospital of Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, Guangdong, 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:

南方医科大学南方医院消化内科 

Primary sponsor:

Digestive System Department, Nanfang Hospital of Southern Medical University 

研究实施负责(组长)单位地址:

广东省广州市广州大道北1838号 

Primary sponsor's address:

1838 North Guangzhou Avenue, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医院

具体地址:

广东省广州市广州大道北1838号

Institution
hospital:

Nanfang Hospital of Southern Medical University

Address:

1838 North Guangzhou Avenue

经费或物资来源:

临床研究专项拨款 

Source(s) of funding:

Clinical research earmarks 

研究疾病:

结直肠侧向发育肿瘤 

Target disease:

laterally spreading tumor 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究的主要目的为,以病理诊断为金标准,评价放大内镜结合结晶紫染色、电子放大内镜、超声内镜术前评估LST的诊断准确性;初步建立并完善大肠 LST 病变内镜术前评估标准,规范国内术前评估 LST病变浸润深度的评估,为提出《中国大肠LST病内镜术前评估指南》提供依据。 

Objectives of Study:

The main purpose of this study was to evaluate the diagnostic accuracy of LST before surgery by using pathological diagnosis as the gold standard, in combination with crystal violet staining, electronic magnifying endoscopy and endoscopic ultrasound. The preoperative evaluation standard of LST endoscopic lesions in the large intestine was preliminarily established and improved, and the domestic preoperative evaluation of LST lesion infiltration depth was standardized, so as to provide the basis for the "guidelines for preoperative evaluation of LST endoscopic lesions in the large intestine of China". 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 18~65 岁,男女不限; 2. 经结肠镜检查诊断为大肠侧向发育型肿瘤; 3. 签署书面知情同意书。 

Inclusion criteria

1. Aged 18 ~ 65 years old, male or female; 2. The tumor was diagnosed as lateral development of large intestine by colonoscopy; 3. Sign written informed consent. 

排除标准:

1.既往有急性心梗病史(6个月内); 2.有严重心、脑、肺、肾合并症; 3.肠梗阻; 4.既往行结肠癌手术; 5.妊娠及哺乳期; 6.需要抗凝治疗,且检查前7天无法停止抗凝治疗。 7.基于医师的评估,该患者的医学状况不适于本项研究。 

Exclusion criteria:

1. Previous history of acute myocardial infarction (within 6 months); 2. Have serious heart, brain, lung, kidney complications; 3. Intestinal obstruction. 4. Previous colon cancer surgery; 5. Pregnancy and lactation; 6. Anticoagulant therapy is required and cannot be stopped 7 days before examination; 7. Based on the physician's assessment, the patient's medical condition was not appropriate for the study. 

研究实施时间:

Study execute time:

From2019-12-01To 2023-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

病理诊断

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

pathological diagnosis

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

放大内镜结合结晶紫染色、电子放大内镜、超声内镜术前评估

Index test:

Combination with crystal violet staining, electronic magnifying endoscopy and endoscopic ultrasound

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

大肠侧向发育型肿瘤

例数:

Sample size:

340

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

lateral development of large intestine tumor

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

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):

南方医院 

单位级别:

三级甲等 

Institution
hospital:

Nanfang Hospital of Southern Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈率

指标类型:

次要指标 

Outcome:

Cure rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

残留率

指标类型:

次要指标 

Outcome:

Residue rate

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:

标本中文名:

组织:

Sample Name:

No

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

N/A

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

N/A

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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):

采用纸质CRF进行数据采集

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

Paper CRF was used for data collection

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:

采用Epidata数据库。 数据录入与管理由统计单位指定数据管理员负责。为保证数据的准确性,应由两数据管理员独立进行双录入并校对。录入过程发现问题或意外情况,应做好登记并及时报告,以便迅速处理问题,数据录入结束后应抽查部分观察表格,了解录入质量,分析并处理存在的问题。

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

Epidata database was used. Data entry and management shall be the responsibility of the data administrator designated by the statistical unit.In order to ensure the accuracy of the data, two data managers should independently enter and proofread the data.If problems or unexpected situations are found in the entry process, registration and timely report should be done so as to deal with problems quickly. After data entry, partial observation forms should be randomly checked to understand the entry quality and analyze and deal with existing problems

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-20
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