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内镜下扩张和支架植入对于顽固性食管良性狭窄回顾性分析
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注册号:

Registration number:

ChiCTR1800016321 

最近更新日期:

Date of Last Refreshed on:

2018-05-25 

注册时间:

Date of Registration:

2018-05-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

内镜下扩张和支架植入对于顽固性食管良性狭窄回顾性分析 

Public title:

The role of endoscopic dilation and stents in refractory benign esophageal strictures: a retrospective analysis. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

内镜下扩张和支架植入治疗食管良性狭窄 

Scientific title:

The role of endoscopic dilation and stents in benign esophageal strictures. 

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:

陆清 

研究负责人:

马洪升 

Applicant:

Lu Qing 

Study leader:

Ma Hongsheng 

申请注册联系人电话:

Applicant telephone:

+86 13438030687 

研究负责人电话:

Study leader's telephone:

+86 13438030687 

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:

237199636@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13438030687@163.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:

四川省成都市武侯区国学巷37号四川大学华西医院 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu1, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2018-68 

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:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

West China Hospital of Sichuan University Biomedical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-17 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

Zuo Zejin 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院 

Contact Address of the ethic committee:

West China hospital of Sichuan University, 37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川大学华西医院 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

West China hospital of Sichuan University, 37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

研究生经费卡 

Source(s) of funding:

Graduate student funding card 

研究疾病:

难治性食管狭窄 

Target disease:

refractory esophageal stricture 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

食管良性狭窄疾病是排除食管恶性狭窄的一大类疾病的总称,其病因包括长时间的酸反流(反流性食管炎)所致的消化性狭窄、腐蚀性狭窄、食管术后吻合口狭窄、ESD术后狭窄,以及继发于局部放射治疗、食管结核所致的狭窄等。内镜下扩张为食管良性狭窄的首选治疗,但是长期随访过程中,大约30%-40%的患者需要数次内镜下扩张,这部分病人表现出对内镜治疗的顽固性。Kochman定义顽固性食管良性狭窄为至少扩张3次以上,食管腔直径仍不能扩至14mm,和/或食管管径达到14mm不能维持4周。部分顽固性食管狭窄疾病患者扩张后暂时安置支架,可以缓解吞咽困难症状,减少扩张次数。目前大部分研究证实扩张和安置支架对于顽固性食管良性狭窄有效,但很难确定经过治疗后狭窄的远期结局,本研究经过长期随访,用于评估顽固性食管良性狭窄经单纯扩张和扩张后安置支架的远期结局。 

Objectives of Study:

Benign stricture of the esophagus is presumed to be a sequela of deep esophageal injury, which stimulates production of fibrous tissue and deposition of collagen, in the absence of endoscopic or pathology evidence of malignant stenosis. Benign stricture of the esophagus includes peptic esophageal strictures caused by long-term acid reflux (reflux esophagitis), caustic esophageal strictures, post-surgical esophageal strictures, post-ESD esophageal strictures, stenosis caused by local radiotherapy, and tuberculosis . The management of some patients with benign esophageal stricture is time-consuming and challenging. Dilation with bougies or balloons is the classic treatment for esophageal stricture , but over 30% of patients needed continuing endoscopic dilation for more than 2 sessions during long-term follow-up . This may be due to refractory strictures that cannot be dilated to an adequate diameter for patients to be dysphagia-free on numerous sessions, or strictures that required short-interval dilation to remain dysphagia-free . Kochman defined RBES as more than 3-5 dilations (either mechanical or pneumatic) having been performed without clinical and endoscopic response or when it was impossible to achieve a 14 mm lumen over 3 dilation sessions . Some studies suggest temporary placement of self-expandable stents for RBES when dilation has failed, though a clear definition of clinical failure has not been uniformly adopted. Stents were left in place to allow for remodeling of the scar tissue, so part patients with RBES could alleviate symptoms of dysphagia and reduce the times of dilation by stents . Current research confirms that both dilation and stents for RBES are effective, but literature is scarce on the clinical efficacy of dilation compared with stent placement. Meanwhile, the long-term outcomes of RBES remain unclear. Our study patients were followed for 6 months and evaluated after least 3 therapy sessions, to assess the long-term outcomes, safety, and therapeutic success of endoscopic therapy in patients with RBES after endoscopic dilation and stents. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)纳入标准:①根据临床表现、胃镜、病理组织学诊断为食管良性狭窄;②符合顽固性食管良性狭窄定义:内镜治疗(包括食管扩张治疗及安置食管支架)3次及3次以上,仍有吞咽困难症状的良性食管狭窄;③完整的电子病历资料和随访信息,包括性别、诊断狭窄时年龄、狭窄的病因、狭窄的部位和长度、狭窄的数量、治疗方式、两次治疗之间的时间间隔、不良事件等。 

Inclusion criteria

(1) they had been diagnosed with esophageal benign stricture according to clinical manifestation, gastroscopy, and pathology; (2) they had persistent symptoms of dysphagia despite ≥ three sessions of endoscopic therapy, and (3) they had complete medical records and follow-up information, including gender, age at first therapy, RBES etiology, number, location, length and diameter of structures, endoscopic therapy, the period between two consecutive endoscopic interventions, and adverse events.  

排除标准:

排除标准:①年龄小于16岁,②内镜治疗少于3次,③病因为先天性食管闭锁术后狭窄、恶性食管狭窄,④首次扩张前出现食管瘘。 

Exclusion criteria:

(1) younger than 16 years old; (2) had received<3 endoscopic interventions; (3) had been diagnosed with congenital esophageal stenosis, malignant esophageal strictures, or with esophageal fistula.  

研究实施时间:

Study execute time:

From2018-05-17To 2018-11-27 

征募观察对象时间:

Recruiting time:

From2018-05-17To 2018-08-24 

干预措施:

Interventions:

组别:

1

样本量:

25

Group:

one

Sample size:

干预措施:

扩张

干预措施代码:

Intervention:

dilaiton

Intervention code:

组别:

2

样本量:

25

Group:

two

Sample size:

干预措施:

支架

干预措施代码:

Intervention:

stent

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

吞咽困难缓解

指标类型:

主要指标 

Outcome:

dysphagia-free

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:

-

组织:

Sample Name:

-

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 16 years
最大 Max age 100 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:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

不共享

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

no share

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:

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

none

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-05-25
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