Today is 2022-07-06

The treatment of gastric submucosal tumor
download

注册号:

Registration number:

ChiCTR2100053933 

最近更新日期:

Date of Last Refreshed on:

2022-05-26 

注册时间:

Date of Registration:

2021-12-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胃黏膜下肿物的治疗 

Public title:

The treatment of gastric submucosal tumor 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

透明帽吸引肿物切除术与内镜黏膜下剥离术切除≤1cm胃黏膜下肿物的单中心、前瞻性、随机对照的非劣效性临床试验 

Scientific title:

Cap-aspiration lumpectomy versus endoscopic submucosal dissection for the treatment of gastric submucosal tumor <=1cm: a single-center, prospective, randomized controlled, non-inferiority clinical 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:

罗晓蓓 

研究负责人:

刘思德 

Applicant:

Luo xiaobei 

Study leader:

Liu Side 

申请注册联系人电话:

Applicant telephone:

+86 17688881428 

研究负责人电话:

Study leader's telephone:

+86 13902212459 

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:

luoxiaobei63@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luoxiaobei63@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

南方医科大学南方医院 

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:

广东省广州市白云区广州大道北1838号 

研究负责人通讯地址:

广东省广州市白云区广州大道北1838号 

Applicant address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong 

Study leader's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong 

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, 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-2021-343 

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:

Ethics Committee of Nanfang Hospital, Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-10-25 

伦理委员会联系人:

刘思德 

Contact Name of the ethic committee:

Liu Side 

伦理委员会联系地址:

广东省广州市白云区广州大道北1838号 

Contact Address of the ethic committee:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 17688881428 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

luoxiaobei63@126.com 

研究实施负责(组长)单位:

南方医科大学南方医院 

Primary sponsor:

Nanfang Hospital, Southern Medical University 

研究实施负责(组长)单位地址:

广东省广州市白云区广州大道北1838号 

Primary sponsor's address:

1838 Guangzhou Avenue North, Baiyun District, 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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

白云区广州大道北1838号

Institution
hospital:

Nanfang Hospital, Southern Medical University

Address:

1838 Guangzhou Avenue North, Baiyun District

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

胃粘膜下肿物 

Target disease:

submucosal tumor 

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:

探索性研究/预试验 

Study phase:

研究目的:

主要目的:比较CASL 与ESD两种不同内镜手术方式对于治疗胃黏膜下肿物的安全性及有效性,从而为国内外胃黏膜下肿物切除的手术方式的选择提供可靠的依据。 

Objectives of Study:

Main purpose: to assess the safety and efficacy of CASL and ESD in the treatment of gastric submucosal tumors, which is to provide a reliable basis for the endoscopic treatment strategy of gastric submucosal tumors. 

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.患者及其家属知情并自愿签署知情同意书; 2.18~65 岁,男女不限; 3.经电子胃十二指肠镜或超声胃镜检查诊断≤1cm胃黏膜下肿物需行内镜下手术治疗。 

Inclusion criteria

1.Patients and their families are informed and voluntarily to sign written informed consent ; 2.Male or female aged 18 to 65 years; 3.Diagnosed with gastric submucosal tumor <=1cm by electronic gastroduodenoscopy or endoscopic ultrasonography. 

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.食管狭窄或幽门梗阻; 4.既往行胃癌手术或息肉检查为恶性病变; 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.Serious complications of heart, brain, lung and kidney; 3.Esophageal stenosis or pyloric obstruction; 4.Previous gastric cancer surgery or polyp examination showed malignant lesions; 5. Pregnancy and lactation; 6. Require anticoagulant therapy which cannot be stopped for 7 days before the examination; 7. Based on the physician's assessment, the patient's medical condition was not suitable for this study. 

研究实施时间:

Study execute time:

From2021-09-01To 2024-04-30 

征募观察对象时间:

Recruiting time:

From2021-12-06To 2024-04-30 

干预措施:

Interventions:

组别:

试验组

样本量:

51

Group:

Experimental group

Sample size:

干预措施:

透明帽吸引肿物切除术

干预措施代码:

Intervention:

Cap-aspiration lumpectomy

Intervention code:

组别:

对照组

样本量:

51

Group:

Control group

Sample size:

干预措施:

内镜黏膜下剥离术

干预措施代码:

Intervention:

Endoscopic submucosal dissection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等 

Institution
hospital:

Nanfang Hospital, Southern Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

手术相关并发症

指标类型:

主要指标 

Outcome:

Surgical complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中出血量

指标类型:

次要指标 

Outcome:

Estimated blood loss

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中动脉搏动性出血及术中其它并发症

指标类型:

次要指标 

Outcome:

Intraoperative pulsatile bleeding and other intraoperative complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后留置鼻胃管

指标类型:

次要指标 

Outcome:

Postoperative indwelling nasogastric tube

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发热

指标类型:

次要指标 

Outcome:

fever

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹痛

指标类型:

次要指标 

Outcome:

stomachache

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后病理

指标类型:

次要指标 

Outcome:

Pathology

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院观察天数

指标类型:

次要指标 

Outcome:

Length of postoperative hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术费用

指标类型:

次要指标 

Outcome:

operation cost

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院总费用

指标类型:

次要指标 

Outcome:

hospitalization cost

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

完整切除

指标类型:

次要指标 

Outcome:

En bloc resection

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

Operating time

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:

标本中文名:

胃粘膜下肿物

组织:

Sample Name:

submucosal tumor

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 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):

研究者使用区组随机分组的方法将尚未确定的102位受试者按1:1的比例随机分入2个组(A组:CASL手术组、B组:ESD手术组).

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

Using the method of block randomization, 102 subjects who have not yet been determined were randomly divided into 2 groups (group A: CASL surgery group, group B: ESD surgery group) by researchers in A 1:1 ratio.

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):

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):

杂志发表

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

Publication on journal

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:

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-03
return list