Observation and study on ear image specific changes and auricular points electrical characteristics in patients with intestinal polyps

注册号:

Registration number:

ITMCTR2022000111

最近更新日期:

Date of Last Refreshed on:

2022-11-29

注册时间:

Date of Registration:

2022-09-22

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

肠道息肉患者的耳像特异性改变及耳穴电特性观察研究

Public title:

Observation and study on ear image specific changes and auricular points electrical characteristics in patients with intestinal polyps

注册题目简写:

English Acronym:

研究课题的正式科学名称:

肠道息肉患者的耳像特异性改变及耳穴电特性观察研究

Scientific title:

Observation and study on ear image specific changes and auricular cavitation electrical characteristics in patients with intestinal polyps

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200066172 ; ChiMCTR2200006825

申请注册联系人:

李青峰

研究负责人:

李青峰

Applicant:

Qingfeng Li

Study leader:

Qingfeng Li

申请注册联系人电话:

Applicant telephone:

18818546462

研究负责人电话:

Study leader's telephone:

18818546462

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:

zn19980@sina.com

研究负责人电子邮件:

Study leader's E-mail:

zn19980@sina.com

申请单位网址(自愿提供):

Study leader's 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:

中国杭州市余杭区仓前街道杭州师范大学勤园13号楼105室

研究负责人通讯地址:

中国杭州市余杭区仓前街道杭州师范大学勤园13号楼105室

Applicant address:

Room 105, Building 13 of Qin Yuan, Hangzhou Normal University, Cangqian Street, Yuhang District, Hangzhou, China

Study leader's address:

Room 105, Building 13 of Qin Yuan, Hangzhou Normal University, Cangqian Street, Yuhang District, Hangzhou, 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:

杭州师范大学公卫学院

Applicant's institution:

School of Public Health, Hangzhou Normal University

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

20220002

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

杭州师范大学公共卫生学院伦理委员会

Name of the ethic committee:

The Ethics Committee, School of Public Health, Hangzhou Normal University

伦理委员会批准日期:

Date of approved by ethic committee:

2022/2/24 0:00:00

伦理委员会联系人:

马珊丹

Contact Name of the ethic committee:

Shandan Ma

伦理委员会联系地址:

中国杭州市余杭区仓前街道杭州师范大学慎园7号楼109

Contact Address of the ethic committee:

Room 109, Building 7 of Shen Yuan, Hangzhou Normal University, Cangqian Street, Yuhang District, Hangzhou, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 571 28860927

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:

杭州师范大学

Primary sponsor:

Hangzhou Normal University

研究实施负责(组长)单位地址:

中国杭州市余杭区仓前街道杭州师范大学

Primary sponsor's address:

Hangzhou Normal University, Cangqian Street, Yuhang District, Hangzhou, 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):

辽宁省

市(区县):

沈阳市

Country:

China

Province:

Liaoning Province

City:

Shenyang City

单位(医院):

辽宁中医药大学附属第三医院

具体地址:

沈阳市和平区十一纬路35号

Institution
hospital:

The Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Address:

No.35, Xi Yiwei Road, Heping District, Shenyang City

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang Province

City:

Hangzhou City

单位(医院):

杭州师范大学附属医院

具体地址:

杭州市拱墅区拱宸桥街道温州路126号

Institution
hospital:

The Affiliated Hospital of Hangzhou Normal University

Address:

No.126, Wenzhou Road, Gongchen Bridge Street, Gongshu District, Hangzhou

经费或物资来源:

课题经费

Source(s) of funding:

Project funds

研究疾病:

肠息肉和肠癌

研究疾病代码:

Target disease:

Intestinal polyps and cancer

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

析因分组(即根据危险因素或暴露因素分组)

Factorial

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

据国家卫建委统计,每年新发结直肠癌患者约52万,结直肠癌死亡约30多万。而预防结直肠癌的主要手段就是筛查,而肠镜的检查是我们常规体检中常常被忽视的项目。同时,肠镜的检查所导致患者的不适感也是造成不愿意做筛查的主要原因。肠道增生或息肉是肠癌的主要诱因,临床上60%会转化为癌症。所以,如果能较早的发现肠道增生,并及时的进行手术切除,就可以更好的防止癌变,减少肠癌的发生。 临床上,我们通过多年观察,发现了一些关于肠息肉及结直肠肿瘤患者的耳穴特异性变化规律,即在刚出现肠道息肉或增生的时候,患者的耳郭上特定区域就会出现丘疹或点片状增生、以及特定穴位生物电特性的改变等。希望通过进一步相关的临床科研,能为肠息肉的诊断提供一种简便、无创的快速筛查方法,为早期肠道肿瘤的预防提供中医特色辅助诊断。

Objectives of Study:

According to the National Health and Construction Commission, there are about 520,000 new colorectal cancer patients and about 300,000 new colorectal cancer deaths every year. The main means to prevent colorectal cancer is screening, and colonoscopy is an often-overlooked item in our routine physical examination. At the same time, colonoscopy'to discomfort is also the main reason for the reluctance to do screening. Intet hyperplasia or polyps is the main cause of bowel cancer, clinical 60% will turn into cancer. Therefore, if the intestinal hyperplasia can be detected earlier, and timely surgical resection, it can better prevent carcinogenesis, reduce the occurrence of bowel cancer. Through years of Clinically observation, we have found some ear-specific changes in intestinal polyps and colorectal cancer, that is, when intestinal polyps or hyperplasia just appear, specific areas of patients ears will appear papules or dotted hyperplasia, as well as the change of bioelectric characteristics of specific acupoints. It is hoped that through further relevant clinical scientific research, it can provide a simple and non-invasive rapid screening method for the diagnosis of intestinal polyps, and provide TCM characteristic auxiliary diagnosis for the prevention of early intestinal tumors.

药物成份或治疗方案详述:

选取肠镜检查确诊有结直肠息肉患者和正常健康者共计250例(其中结直肠息肉患者125例、正常健康者125例),采集患者其耳穴穴位电阻抗和耳轮脚肠道穴区的耳像特异性照片。 1、电测穴位:根据耳穴理论,取12个穴位,其中包含主要部位穴“十二指肠、小肠、大肠、直肠、肛门、内分泌、三焦、艇中、胰胆”以及对照穴:“肛门、内生殖器、角窝中、腹痛点、心、肺”;和3个肿瘤特异区(M1、M2、M3)。取穴根据"耳穴名称与定位《国家标准》"(GB/T 13734-2008);肿瘤特异区参考中国中医研究院针灸研究室主编的"耳穴挂图"和翟传琪提出的肿瘤特异区(肿瘤特异区1(MI);在耳部正面,距耳垂后缘向前约3 mm,从轮垂切迹至耳垂下缘中点的一条弧线。肿瘤特异区2(M2)∶在耳舟后隆起与耳轮游离缘之间,自耳轮结下缘至与耳轮脚同水平的耳轮间的弧线。肿瘤特异区3(M3)∶在与肿瘤特异区1相对应的耳垂背部边缘上。 操作方法:用75%酒精轻拭待测穴位,并用干棉球擦干,静待5分钟。将参考电极贴片固定于同侧手腕内关穴,检测者持SZF耳穴探测笔先测定患者的基准定标穴,定标完成后,再测试耳穴相关穴位。在每个穴区的重复测量3次,由微机自动记录获得该穴区电阻抗。 2、耳穴视诊:用高清相机采集患者耳像。 操作方法:让受检者取坐位,充分暴露耳郭,用高清相机通过固定光源拍摄耳轮脚周围图像。获取患者左右耳“小肠、大肠”区的耳像照片,在相应的区域观察是否有点片状增生或丘疹的特异性改变,并由操作者在图片上标注出来。 3、通过采集的数据进行耳像特征标注分析和相关耳穴穴位生物电特异性统计分析,并总结成果撰写发表论文。

Description for medicine or protocol of treatment in detail:

纳入标准:

1.病例组:结肠镜检查发现结肠息肉(包括结直肠息肉、结直肠多发息肉)或接受肠息肉高频电凝切术的患者;对照组:结肠镜检查诊断未患结直肠息肉的正常人。 2.一般情况良好,无严重疾病者; 3.年龄在15-85岁之间,男女性别不限。

Inclusion criteria

1.Case group: Patients with colonoscopy finding of colon polyps (including colorectal polyps, multiple colorectal polyps) or undergoing high-frequency electrocoagulation of intestinal polyps; Control group: normal people with no diagnosis of colorectal polyps diagnosed by colonoscopy. 2.In general, in good condition, without serious illness; 3.Age is between 15-85 years, and gender is unlimited.

排除标准:

1.病例组:结肠镜检查结果为结肠炎(包括慢性结肠炎和溃疡性结肠炎)的患者或是未发现结直肠息肉者; 2.耳部畸形,耳部局部病变(包括疤痕、感染、溃烂、破损等)影响观察者; 3.符合入选标准,因各种原因未完成本实验、耳穴电测数据不完整、耳郭图像资料不全者。

Exclusion criteria:

1.Case group: Patients with colonoscopy results of colitis including chronic colitis and ulcerative colitisor those with no colorectal polyps found; 2.Ear deformity and local ear lesions affect the observerincluding scars, infection, ulceration, damage. etc.; 3.Those who meet the selection criteria, fail to complete the experiment, have incomplete ear hole electrical measurement data, and have incomplete ear point image data due to various reasons.

研究实施时间:

Study execute time:

From 2022-12-01

To      2023-12-31

征募观察对象时间:

Recruiting time:

From 2022-12-01

To      2023-04-30

干预措施:

Interventions:

组别:

肠息肉组

样本量:

125

Group:

Case group

Sample size:

干预措施:

进行耳穴生物电测量记录;并进行耳像特异性观察和标注

干预措施代码:

Intervention:

Record of ear acupoints bioelectrical measurements and acupoint image-specificity observation and annotation were performed

Intervention code:

组别:

非肠息肉组

样本量:

125

Group:

Control group

Sample size:

干预措施:

进行耳穴生物电测量记录;并进行耳像特异性观察和标注

干预措施代码:

Intervention:

Record of ear acupoints bioelectrical measurements and acupoint image-specificity observation and annotation were performed

Intervention code:

样本总量 Total sample size : 250

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang Province

City:

Hangzhou City

单位(医院):

杭州师范大学附属医院

单位级别:

三级乙甲等

Institution/hospital:

The Affiliated Hospital of Hangzhou Normal University

Level of the institution:

Grade III B A

国家:

中国

省(直辖市):

辽宁省

市(区县):

沈阳市

Country:

China

Province:

Liaoning Province

City:

Shenyang City

单位(医院):

辽宁中医药大学附属第三医院

单位级别:

三级甲等

Institution/hospital:

The Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution:

Grade III A

测量指标:

Outcomes:

指标中文名:

耳像特异性观察

指标类型:

次要指标

Outcome:

and acupoint image-specificity observation

Type:

Secondary indicator

测量时间点:

对门诊上进行要进行结肠镜检查的患者,在安静的状态,保持恒定26度室温下,拍摄患者左右耳耳像照片以及舌面照片。

测量方法:

采用妙郎中SaaS-100B专用耳像采集系统,该系统外置镜头带遮光罩和补光功能,可以保证采集图像色值的准确性性。患者取座位,用发帖固定耳郭附近的头发防止遮挡。将避光罩放置于患者的耳郭上,打开内置镜头无色补光灯,当镜头自动对焦清晰后,按下镜头把手上的拍照采集按键,完成耳像采集。同样方法采集另一侧耳郭照片。在采集完耳像照片后,再采集舌像照片。每次采集完,用酒精棉球擦拭消毒避光罩后,备下次使用。

Measure time point of outcome:

Measure method:

指标中文名:

耳穴生物电检测

指标类型:

主要指标

Outcome:

ear acupoints bioelectrical measurements

Type:

Primary indicator

测量时间点:

对门诊上进行要进行结肠镜检查的患者,在安静的状态下,保持恒定26度室温下,进行耳穴生物电检测。

测量方法:

将导联电极片贴在患者手腕内侧,用SZF耳穴检测笔依次对选取的耳穴穴位经行检测,该耳穴检测笔使用恒定压力探头,保持在恒定压力情况下,探测穴位的生物阻抗,并记录每穴穴位检测的数值。

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:

尚未开始

Not yet recruiting

年龄范围:

最小 15
Min age years
最大 85
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由志愿服务者向门诊挂号肠道科就诊患者,发放招募书,患者自愿填写知情同意书,按照报名顺序产生序列。经肠镜检查确诊肠息肉患者进入病例组,非肠息肉患者进入对照组。

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

Volunteers will register to the outpatient intestinal department, issue the recruitment letter, and the patients will voluntarily fill in the informed consent form, and produce the sequence according to the registration order. Patients with confirmed intestinal polyps by colonoscopy entered the case group, and patients

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

发布科研数据

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

Release scientific research data

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:

1、入组患者的肠镜检查报告 2、耳穴电测记录表 3、左右耳耳像照片

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

1. Colorectal report of the enrolled patients 2. Bioelectric characteristics record table of the ear acupoints 3. Photos of the left and right ears

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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