今天是:2021-03-05 星期五

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 胆总管结石的外科治疗
下载XML文档

注册号:

Registration number:

ChiCTR1900024765 

最近更新日期:

Date of Last Refreshed on:

2019-07-26 

注册时间:

Date of Registration:

2019-07-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 胆总管结石的外科治疗 

Public title:

Surgical treatment of common bile duct stones 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改良“一步法”腹腔镜+胆道镜置入自脱落式支架免T管与“二步法”内镜取石+腹腔镜处理胆总管结石的对照研究 

Scientific title:

Comparative Study of Modified 'Single-Stage' versus 'Two-Stage' in the treatment of choledocholithiasis 

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:

王强 

研究负责人:

薛东波 

Applicant:

Qiang Wang 

Study leader:

DongboXue 

申请注册联系人电话:

Applicant telephone:

+86 13258661882 

研究负责人电话:

Study leader's telephone:

+86 13845103698 

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:

wq1171415797@163.om 

研究负责人电子邮件:

Study leader's E-mail:

dongbo_xue@126.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:

哈尔滨市南岗区邮政街23号 

研究负责人通讯地址:

哈尔滨市南岗区邮政街23号 

Applicant address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, China 

申请注册联系人邮政编码:

Applicant postcode:

150001 

研究负责人邮政编码:

Study leader's postcode:

150001 

申请人所在单位:

哈尔滨医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Harbin Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

哈尔滨医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Harbin Medical University 

研究实施负责(组长)单位地址:

哈尔滨市南岗区邮政街23号 

Primary sponsor's address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

Haerbin

单位(医院):

哈尔滨医科大学附属第一医院

具体地址:

哈尔滨市南岗区邮政街23号

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University

Address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, China

经费或物资来源:

中国自然科学基金 

Source(s) of funding:

the National Natural Science Foundation of China 

研究疾病:

胆总管结石 

Target disease:

common bile duct stones 

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:

本研究的目的是探讨两种微创外科手术治疗胆囊结石合并胆总管结石的临床价值 

Objectives of Study:

The purpose of this study was to investigate the clinical value of two minimally invasive surgical procedures for treating patients with concomitant gallstones and common bile duct stones. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

中国哈尔滨医科大学附属第一医院普外科收治的胆囊结石合并胆总管结石患者。其中有34例行改良“一步法”手术,即全麻下行LC+LCBDE,置入自脱落式内支架并免除留置T管。在施行“二步法”手术(即一期全麻下行传统ERCP+EST/EPBD+ENBD术式,二期再择期行LC)的患者中,依照年龄、性别构成比、伴发内科基础疾病,术前血清直接胆红素、血淀粉酶等指标与“一步法”组相匹配的原则,筛选出84例。 

Inclusion criteria

patients with concomitant gallstones and common bile duct stones who were treated in the Department of General Surgery of First Affiliated Hospital of Harbin Medical University, Harbin, China were included in this study. Of these patients, 63 patients underwent a modified 'single-stage' procedure under general anesthesia, namely, LC plus LCBDE were performed, and a spontaneously removed biliary stent without a T-tube was placed for drainage. Based on age, gender ratio, complicating medical diseases, preoperative serum direct bilirubin level and serum amylase level, which were comparable to those in the 'single-stage' group, 84 patients were selected from among patients undergoing the 'two-stage' procedure in which, under general anesthesia, ERCP plus endoscopic sphincterotomy (EST)/endoscopic papillary balloon dilatation (EPBD) plus endoscopic nasobiliary drainage (ENBD) were performed at stage I, and LC was performed at stage II. 

排除标准:

排除了术前并发急性胰腺炎的患者。 

Exclusion criteria:

Patients with preoperative acute pancreatitis. 

研究实施时间:

Study execute time:

From2019-08-01To 2019-10-30 

征募观察对象时间:

Recruiting time:

From2019-08-01To 2019-12-30 

干预措施:

Interventions:

组别:

Two groups

样本量:

118

Group:

Two groups

Sample size:

干预措施:

Single-Stage versus Two-Stage operation

干预措施代码:

Intervention:

Single-Stage versus Two-Stage operation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Haerbin 

单位(医院):

哈尔滨医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University, Youzheng Street 23, Harbin, China. 150001  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后住院日数

指标类型:

主要指标 

Outcome:

Postoperative length of hospitalization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

主要指标 

Outcome:

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:

总住院日数

指标类型:

主要指标 

Outcome:

Total length of hospitalization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

主要指标 

Outcome:

Medical costs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内支架排出日数

指标类型:

主要指标 

Outcome:

The number of days until the stent was passed through

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹部X线检查

指标类型:

主要指标 

Outcome:

Abdominal X-ray examination

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:

没有

组织:

Sample Name:

none

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 26 years
最大 Max age 70 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

中国哈尔滨医科大学附属第一医院普外科收治的胆囊结石合并胆总管结石患者。其中有34例行改良“一步法”手术,即全麻下行LC+LCBDE,置入自脱落式内支架并免除留置T管。在施行“二步法”手术(即一期全麻下行传统ERCP+EST/EPBD+ENBD术式,二期再择期行LC)的患者中,依照年龄、性别构成比、伴发内科基础疾病,术前血清直接胆红素、血淀粉酶等指标与“一步法”组相匹配的原则,筛选出84例。

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

联系作者本人

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

Contact me

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:

没有

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

none

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-26
返回列表