ChiCTR2000035187 版本V1.3 版本创建时间2020/8/3 3:03:55 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000035187 

最近更新时间:

Date of Last Refreshed on:

2020/8/3 3:02:11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

不同容量治疗方案对于胰腺肿瘤手术患者 围术期肠道菌群的影响 

Public title:

Effects of different volume treatment regimens on perioperative intestinal flora of patients undergoing pancreatic tumor surgery 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

不同容量治疗方案对于胰腺肿瘤手术患者 围术期肠道菌群的影响 

Scientific title:

Effects of different volume treatment regimens on perioperative intestinal flora of patients undergoing pancreatic tumor surgery 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陆肖坚 

研究负责人:

陆肖坚 

Applicant:

Lu Xiaojian 

Study leader:

Lu Xiaojian 

申请注册联系人电话:

Applicant telephone:

+86 13671623846 

研究负责人电话:

Study leader's telephone:

+86 13671623846 

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:

luxiaojian1989@163.com 

研究负责人电子邮件:

Study leader's E-mail:

luxiaojian1989@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:

中国上海市瑞金二路197号瑞金医院麻醉科 

研究负责人通讯地址:

中国上海市瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine 

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:

2020临伦第103号 

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:

瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hosptial Ethics Connittee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-15 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

上海交通大学医学院附属瑞金医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Ruijin Hosptial affiliated to Shanghai Jiao Tong University School of Medician 

研究实施负责(组长)单位地址:

中国上海市瑞金二路197号瑞金医院 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号

Institution
hospital:

Ruijin Hosptial affiliated to Shanghai Jiao Tong University School of Medician

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised funds 

研究疾病:

胰腺癌 

Target disease:

Pancreatic cancer 

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:

其它 

Study phase:

N/A 

研究目的:

研究不同容量治疗方案对于胰腺肿瘤手术患者围术期肠道菌群微环境是否存在影响。 

Objectives of Study:

To investigate the effects of different volume treatment regimens on perioperative intestinal microenvironment of patients undergoing pancreatic tumor surgery. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、 限期本研究中心行胰腺肿瘤手术患者; 2、 年龄≥18岁; 3、 ASA分级1-2级 4、 患者无严重心、肺、肾相关疾病合并症,无严重代谢类疾病; 5、 患者术前不伴有肠梗阻、肠穿孔、严重肝肾功能损伤等疾病,未行PTCD、ENBD及其他胃肠手术; 6、 术前一年内未接受过益生菌治疗;术前3个月内无抗生素使用病史。 

Inclusion criteria

1. Patients undergoing pancreatic tumor surgery in this research center; 2. Aged >=18 years; 3. ASA level 1-2; 4. The patient had no serious complications of heart, lung and kidney diseases, and no serious metabolic diseases; 5. The patient was not preoperatively accompanied by intestinal obstruction, intestinal perforation, severe liver and kidney function injury and other diseases; PTCD, ENBD and other gastrointestinal operations were not performed; 6. Did not receive probiotic treatment within one year before surgery; No history of antibiotic use within 3 months before surgery. 

排除标准:

1、 术前2天内及术后6-8日未能采集到患者粪便样本; 2、 术后采集患者粪便样本前出现非预期二次手术患者; 3、 术前2天内服用泻药进行肠道准备患者; 4、 患者术前心脏超声检查LVEF<50%,近三个月内发生过心梗;肺功能检查FEV1<50%;肾功能不全,血肌酐水平超过正常值上限50%; 5、 术前存在感染,严重内分泌疾病,严重血液系统疾病,神经系统疾病,脑血管病变史及精神疾病患者; 6、 术中出现严重过敏、短期大量失血等需要抢救的患者。 7、 对本研究存在顾虑,不愿意接受的患者。 

Exclusion criteria:

1. No stool samples were collected within 2 days before surgery and 6-8 days after surgery; 2. Unexpected secondary surgery patients before postoperative stool samples were collected; 3. Take laxative for intestinal preparation within 2 days before surgery; 4. Preoperative cardiac ultrasound examination of the patient showed LVEF < 50% and myocardial infarction occurred in the past three months; Lung function test FEV1 < 50%; Renal insufficiency, blood creatinine level exceeded the upper limit of normal value by 50%; 5. Preoperative infection, severe endocrine disease, severe blood system disease, nervous system disease, cerebrovascular disease history and mental disease; 6. Patients with severe allergies and short-term massive blood loss during the operation need to be rescued. 7. Patients who have concerns about this study and are unwilling to accept it. 

研究实施时间:

Study execute time:

From2020-08-17To 2022-02-16 

干预措施:

Interventions:

组别:

宽松输液组

样本量:

30

Group:

Group 1

Sample size:

干预措施:

术中宽松输液

干预措施代码:

Intervention:

adequate fluid supplementation

Intervention code:

组别:

目标导向容量填充

样本量:

30

Group:

Group 2

Sample size:

干预措施:

目标导向输液

干预措施代码:

Intervention:

GDFT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三甲医院 

Institution
hospital:

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medician  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肠道菌群多样性

指标类型:

主要指标 

Outcome:

Diversity of intestinal flora

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中输液量

指标类型:

次要指标 

Outcome:

Intraoperative infusion volume

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后体温

指标类型:

附加指标 

Outcome:

Postoperative body temperature

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后血生化指标

指标类型:

附加指标 

Outcome:

7/5000 Postoperative blood biochemical indexes

Type:

Additional 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:

粪便

组织:

Sample Name:

feces

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:

尚未开始

Pending

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):

随机数字表法

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

Random number table method

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

临床试验公共管理平台 www.medresman.org.cn

Data management Institution:

Resman Research mananger www.medresman.org.cn

资料分析单位:

Resman Research mananger

Data analysis Institution:

Resman Research mananger

注册人:

Name on Registration:

 2020-08-02