Today is 2019-12-10

Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection
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注册号:

Registration number:

ChiCTR1900027644 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

开腹清创灌洗术与小切口引流术在胰腺假性囊肿合并感染中的前瞻、随机、多中心对照研究 

Public title:

Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

开腹清创灌洗术与小切口引流术在胰腺假性囊肿合并感染中的前瞻、随机、多中心对照研究 

Scientific title:

Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection 

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:

徐新建 

研究负责人:

徐新建 

Applicant:

Xinjian XU 

Study leader:

Xinjian XU 

申请注册联系人电话:

Applicant telephone:

+86 18599025120 

研究负责人电话:

Study leader's telephone:

+86 18599025120 

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:

krron@163.com 

研究负责人电子邮件:

Study leader's E-mail:

krron@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:

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 

研究负责人通讯地址:

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 

Applicant address:

137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China 

Study leader's address:

137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, China 

申请注册联系人邮政编码:

Applicant postcode:

830054 

研究负责人邮政编码:

Study leader's postcode:

830054 

申请人所在单位:

新疆医科大学第一附属医院消化血管外科中心胰腺外科 

Applicant's institution:

Department of Pancreatic Surgery, Center of digestive & vascular medicine, The First Affiliated Hospital of Xinjiang 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:

20180622-07 

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:

新疆医科大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics committee of the first affiliated hospital of xinjiang medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-21 

伦理委员会联系人:

罗坤 

Contact Name of the ethic committee:

Kun Luo 

伦理委员会联系地址:

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 

Contact Address of the ethic committee:

137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, 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:

新疆医科大学第一附属医院消化血管外科中心胰腺外科 

Primary sponsor:

Department of Pancreatic Surgery, Center of digestive & vascular medicine, The First Affiliated Hospital of Xinjiang Medical University 

研究实施负责(组长)单位地址:

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号 

Primary sponsor's address:

137 Li-Yu-Shan Road, Urumqi, Xinjiang Uygur Autonomous Region, 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):

新疆维吾尔自治区

市(区县):

乌鲁木齐市

Country:

China

Province:

Xinjiang Uygur Autonomous Region

City:

Urumqi

单位(医院):

新疆医科大学第一附属医院

具体地址:

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号

Institution
hospital:

The First Affiliated Hospital of Xinjiang Medical University

Address:

137 Li-Yu-Shan Road

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

胰腺假性囊肿合并感染 

Target disease:

Pancreatic pseudocyst with infection 

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:

研究开腹微创外引流与传统外引流术的优缺点对比 

Objectives of Study:

To compare the advantages and disadvantages of minimally invasive external drainage with traditional external drainage 

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.获得受试者的知情同意书; 2.临床治愈已度过急性期,病情稳定后再次病情恶化,不能进食或体温高烧持续1周以上; 3.增强CT显示:腹腔内或胰周病灶出现“气泡征”; 4.排除肺部感染、导管感染、尿路感染等非胰腺引起的发热或病情恶化; 5.在手术前7天内,有足够的肝肾功能,合适的实验室指标(治疗后):中性粒细胞≥1500/mm3,PLT≥50×109/L,血清ALB≥28g/L。TBIL<2mg/dL,ALT、AST<5倍正常值上限值,Bun、Cr<1.5倍正常值上限值,INR<1.7或PT延长<4s。 

Inclusion criteria

1. Obtain informed consent from the subject; 2. The clinical cure has passed the acute phase, and the condition deteriorates again after the condition is stable, and the patient cannot eat or the fever lasts for more than 1 week; 3. Enhanced CT showed "bubble sign" in intraperitoneal or peripancreatic lesions; 4. Exclude pulmonary infection, catheter infection, urinary tract infection and other non-pancreatic fever or deterioration; 5. Within 7 days before the operation, there was sufficient liver and kidney function, appropriate laboratory indicators (after treatment) : neutrophils >=1500/mm3, PLT>=50x10^9/L, and serum ALB>=28g/L. TBIL < 2mg/dL, ALT and AST < 5 times normal value, Bun and Cr < 1.5 times normal value, INR < 1.7 or PT extension < 4s. 

排除标准:

1.充血性心力衰竭>纽约心脏协会(NYHA)分级2级; 2.有无法控制的高血压; 3.有人类免疫缺陷病毒(HIV)感染病史; 4.肾衰竭或肾功能不足、需要进行血液或腹膜透析; 5.严重活动性临床感染(>2级,NCI-CTCAE版本4.0); 6.除外术前4周内出现上消化道出血或有明确消化道出血倾向; 7.怀孕中或正在哺乳的受试者; 8.开始试验前4周内有过大手术的患者或尚未从这类手术的副作用中恢复的患者; 9.诊断为胰腺肿瘤患者,如:囊腺瘤(既往3年前已治愈者可纳入)。 

Exclusion criteria:

1.Congestive heart failure > New York heart association (NYHA) grade 2; 2. Uncontrolled high blood pressure; 3. A history of human immunodeficiency virus (HIV) infection; 4. Renal failure or insufficiency, requiring hemodialysis or peritoneal dialysis; 5. Severe active clinical infection (> level 2, nci-ctcae version 4.0); 6. Except for upper gastrointestinal bleeding or clear tendency of gastrointestinal bleeding within 4 weeks before surgery; 7. Subjects who are pregnant or breast-feeding; 8. Patients who had major surgery 4 weeks before the trial or who had not yet recovered from the side effects of such surgery; 9. Patients diagnosed with pancreatic neoplasms, such as cystadenoma (those who had been cured 3 years earlier could be included). 

研究实施时间:

Study execute time:

From2020-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

实验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

微创开腹外引流术

干预措施代码:

Intervention:

Minimally invasive open external drainage

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

开腹清创灌洗术

干预措施代码:

Intervention:

Open debridement lavage

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

乌鲁木齐市 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

Urumqi 

单位(医院):

新疆医科大学第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后胰瘘

指标类型:

主要指标 

Outcome:

POPF

Type:

Primary indicator 

测量时间点:

术后3天

测量方法:

实验室指标

Measure time point of outcome:

Measure method:

指标中文名:

术后胆瘘

指标类型:

主要指标 

Outcome:

Postoperative biliary fistula

Type:

Primary indicator 

测量时间点:

术后3天

测量方法:

胆汁引流量

Measure time point of outcome:

Measure method:

指标中文名:

术后肠瘘

指标类型:

主要指标 

Outcome:

Postoperative intestinal fistula

Type:

Primary indicator 

测量时间点:

术后3天

测量方法:

肠液引流量

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

主要指标 

Outcome:

postoperative complication

Type:

Primary indicator 

测量时间点:

术后至患者出院

测量方法:

Clavien-Dindo分级系统

Measure time point of outcome:

Measure method:

指标中文名:

感染的发生率

指标类型:

主要指标 

Outcome:

Incidence of infection

Type:

Primary indicator 

测量时间点:

术后至患者出院

测量方法:

实验室指标

Measure time point of outcome:

Measure method:

指标中文名:

平均住院天数

指标类型:

主要指标 

Outcome:

Average length of stay

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:

血液

组织:

血液

Sample Name:

blood

Tissue:

blood

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

尿液

Sample Name:

urine

Tissue:

urine

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

采用计算机产生一个随机数表,密封于一个不透明的信封,以保证对参与研究的人员保密。信封在手术时由科研秘书(一个对研究内容未知的人员)打开,告知主刀医师手术方式。

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

A table of random Numbers was generated by a computer and sealed in an opaque envelope to keep the participants confidential.The envelope is opened at the time of the operation by the research secretary (who is not aware of the contents of the study) to inform the surgeon of the procedure.

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

新疆医科大学第一附属医院

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

The First Affiliated Hospital of Xinjiang Medical University

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:

新疆医科大学第一附属医院

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

The First Affiliated Hospital of Xinjiang Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-22
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