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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
南方医科大学南方医院 |
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Applicant's institution: |
Nanfang Hospital, Southern Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Ethics Committee of Nanfang Hospital, Southern Medical University |
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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 |
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Contact Name of the ethic committee: |
Liu Side |
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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 |
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Contact Address of the ethic committee: |
1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China |
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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 |
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Primary sponsor: |
Nanfang Hospital, Southern Medical University |
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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 |
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Primary sponsor's address: |
1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
无 |
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Source(s) of funding: |
None |
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研究疾病: |
胃粘膜下肿物 |
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Target disease: |
submucosal tumor |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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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。 |
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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: |
从From2021-09-01至To 2024-04-30 |
征募观察对象时间: Recruiting time: |
从From2021-12-06至To 2024-04-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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