注册号: Registration number: |
ChiCTR-OOC-15006118 |
最近更新日期: Date of Last Refreshed on: |
2015-03-21 |
注册时间: Date of Registration: |
2015-03-20 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
胰腺囊性病变内镜下诊治的规范化研究 |
Public title: |
The Standardization Research for Endoscopic Diagnosis and Treatment of Pancreatic Cystic Lesions |
注册题目简写: |
|
English Acronym: |
|
研究课题的正式科学名称: |
胰腺囊性病变内镜下诊治的规范化研究 |
Scientific title: |
The Standardization Research for Endoscopic Diagnosis and Treatment of Pancreatic Cystic Lesions |
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: |
姚双喆 |
研究负责人: |
令狐恩强 |
Applicant: |
Yao Shuangzhe |
Study leader: |
Linghu Enqiang |
申请注册联系人电话: Applicant telephone: |
+86 18612032464 |
研究负责人电话: Study leader's telephone: |
+86 13501233558 |
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: |
yaoshuangzhe@126.com |
研究负责人电子邮件: Study leader's E-mail: |
linghuenqiang@vip.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: |
北京市海淀区复兴路28号中国人民解放军总医院消化科 |
研究负责人通讯地址: |
北京市海淀区复兴路28号中国人民解放军总医院消化科 |
Applicant address: |
No. 28 Fuxing Road, Haidian District, Beijing |
Study leader's address: |
No. 28 Fuxing Road, Haidian District, Beijing |
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: |
中国人民解放军总医院 |
||
Applicant's institution: |
The General Hospital of Chinese People's Liberation Army |
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: |
S2014-108-01 |
伦理委员会批件附件: Approved file of Ethical Committee: |
|
批准本研究的伦理委员会名称: |
中国人民解放军总医院医学伦理委员会 |
||
Name of the ethic committee: |
Committee of medical ehthics of the Chinese PLA General Hospital. |
||
伦理委员会批准日期: Date of approved by ethic committee: |
2014-11-18 | ||
伦理委员会联系人: |
|
||
Contact Name of the ethic committee: |
|
||
伦理委员会联系地址: |
|
||
Contact Address of the ethic committee: |
|
||
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: |
中国人民解放军总医院消化科 |
||||||||||||||||||||||
Primary sponsor: |
Department of Gastroenterology of Chinese PLA General Hospital |
||||||||||||||||||||||
研究实施负责(组长)单位地址: |
北京市海淀区复兴路28号中国人民解放军总医院消化科 |
||||||||||||||||||||||
Primary sponsor's address: |
No. 28 Fuxing Road, Haidian District, Beijing |
||||||||||||||||||||||
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||
经费或物资来源: |
军队科研经费 |
||||||||||||||||||||||
Source(s) of funding: |
Scientific Research Funds of Army |
||||||||||||||||||||||
研究疾病: |
胰腺囊性病变 |
||||||||||||||||||||||
Target disease: |
Pancreatic Cystic Lesions |
||||||||||||||||||||||
研究疾病代码: |
|
||||||||||||||||||||||
Target disease code: |
|
||||||||||||||||||||||
研究类型: |
观察性研究 |
||||||||||||||||||||||
Study type: |
Observational study |
||||||||||||||||||||||
研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
||||||||||||||||||||||
研究目的: |
通过对胰腺囊性病变患者的内镜和影像学、病理及分子生物学检查,旨在探讨OCT和超细内镜在胰腺囊性病变诊断中的意义,超声内镜对胰腺囊性病变的诊断价值及聚桂醇囊肿消融治疗对预后的影响,为临床的规范化治疗提供指导。 |
||||||||||||||||||||||
Objectives of Study: |
To evaluate the clinical utility and safety of Optical Coherence Tomography and SpyGlass system for diagnosisof pancreatic cyst, and the treatment effects of lauromacrogol cyst ablation. |
||||||||||||||||||||||
药物成份或治疗方案详述: |
|
||||||||||||||||||||||
Description for medicine or protocol of treatment in detail: |
|
||||||||||||||||||||||
研究设计: |
单臂 |
||||||||||||||||||||||
Study design: |
Single arm |
||||||||||||||||||||||
纳入标准: |
(1)消化科就诊行影像学检查发现胰腺囊性病变者;(2)既往诊断胰腺囊性肿瘤可疑恶性,直径小于3cm者;(3)确诊为恶性无法耐受手术或拒绝手术者;(4)签署知情同意书。 |
||||||||||||||||||||||
Inclusion criteria |
(1) imaging examination suggesting pancreatic cystic lesion; (2) prior diagnosis of pancreatic cystic tumor that suspected malignant and diameter less than 3cm; (3) diagnosed as malignant tumorand cannot tolerate surgery or refuse to attend the study; (4) signed informed consent. |
||||||||||||||||||||||
排除标准: |
(1)不能耐受内镜检查者;(2)有内镜检查禁忌的患者;(3)凝血功能障碍者;(4)证据表明有急性胰腺炎或胰腺感染者。 |
||||||||||||||||||||||
Exclusion criteria: |
(1) cannot tolerate endoscopy; (2) patients with endoscopic taboo; (3) coagulation function disorder; (4) evidence of acute pancreatitis or pancreatic infection. |
研究实施时间: Study execute time: |
从From2014-10-01至To 2017-12-01 |
征募观察对象时间: Recruiting time: |
从From2015-03-20至To 2017-12-01 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|
采集人体标本:
Collecting sample(s)
|
|
征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
|
||||||
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): |
非随机 |
||||||||
Randomization Procedure (please state who generates the random number sequence and by what method): |
No Randomization |
盲法: |
|
Blinding: |
|
试验完成后的统计结果(上传文件): |
|
Calculated Results after
|
|
原始数据公开时间: The time of sharing IPD: |
即时公开/Real time access |
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): |
中国人民解放军总医院消化科 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Department of gastroenterology of Chinese PLA General Hospital |
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: |
中国人民解放军总医院消化科 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Department of gastroenterology of Chinese PLA General Hospital |
数据管理委员会: Data Managemen Committee: |
暂未确定/Not yet |