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橄榄油脂肪乳与中长链脂肪乳在食管癌患者术后肠外营养治疗中对免疫功能影响的比较
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注册号:

Registration number:

ChiCTR-TRC-13003562 

最近更新日期:

Date of Last Refreshed on:

2016-03-05 

注册时间:

Date of Registration:

2013-08-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

橄榄油脂肪乳与中长链脂肪乳在食管癌患者术后肠外营养治疗中对免疫功能影响的比较 

Public title:

Effects of parenteral nutrition with Olive and MCT/LCT based lipid emulsions on immune function in esophageal cancer patient undergoing surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

橄榄油脂肪乳与中长链脂肪乳在食管癌患者术后肠外营养治疗中对免疫功能影响的比较 

Scientific title:

Effects of parenteral nutrition with Olive and MCT/LCT based lipid emulsions on immune function in esophageal cancer patient undergoing surgery: A prospective, controlled, randomized,blinded, paralleled study 

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:

王武平 

研究负责人:

闫小龙 

Applicant:

Wuping Wang 

Study leader:

Xiaolong Yan 

申请注册联系人电话:

Applicant telephone:

+86 029-84717569 

研究负责人电话:

Study leader's telephone:

+86 029-84717569 

申请注册联系人传真 :

Applicant Fax:

+86 029-84717569 

研究负责人传真:

Study leader's fax:

+86 029-84717569 

申请注册联系人电子邮件:

Applicant E-mail:

wwp._8@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wwp._8@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://tdwww.fmmu.edu.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://tdwww.fmmu.edu.cn/ 

申请注册联系人通讯地址:

中国陕西西安市第四军医大学唐都医院新寺路1号 

研究负责人通讯地址:

中国陕西西安市第四军医大学唐都医院新寺路1号 

Applicant address:

1 Xinsi road, Tangdu Hospital, Xi'an, Shaanxi, China 

Study leader's address:

1 Xinsi road, Tangdu Hospital, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710038 

研究负责人邮政编码:

Study leader's postcode:

710038 

申请人所在单位:

陕西省西安市第四军医大学唐都医院 

Applicant's institution:

Tangdu Hospital, The fourth military 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:

TDLL-20130385 

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:

第四军医大学唐都医院伦理委员会 

Name of the ethic committee:

Tangdu Hospital Ethics Committees in Fourth Military Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-06 

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:

第四军医大学唐都医院 

Primary sponsor:

Tangdu Hospital, The fourth military medical university 

研究实施负责(组长)单位地址:

陕西省西安市第四军医大学唐都医院新寺路1号 

Primary sponsor's address:

1 Xinsi road, Tangdu Hospital, Xi'an, Shaanxi, 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):

陕西

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

唐都医院

具体地址:

陕西省西安市第四军医大学唐都医院新寺路1号

Institution
hospital:

Tangdu Hospital

Address:

1 Xinsi road, Tangdu Hospital, Xi'an, Shaanxi, China

经费或物资来源:

自筹 

Source(s) of funding:

self supported 

研究疾病:

食管癌 

Target disease:

Esophageal cancer 

研究疾病代码:

C15 

Target disease code:

C15 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价食管癌患者肠外营养支持中使用橄榄油脂肪乳和中长链脂肪乳的效果,特别是对临床转归、免疫功能、肝肾功能等的影响。 

Objectives of Study:

To assess the effects of PN with olive-oil-based lipid emulsion (ClinOleic) and MCT/LCT fat emulsion (Lipofundin) in esophageal cancer patient undergoing surgery especially on clinical outcome,immune system and the function of liver and kidney etc. 

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:

所有入组实验的患者均确诊为食管癌而需要行食管癌切除并食管重建手术,性别不限,年龄介于35-70岁之间,通过伦理委员会同意后,均签署知情同意书。 

Inclusion criteria

All patients enrolled in this study are those need radical esophagectomy for esophageal carcinoma, either male or female, the age range from 35 to 70 years old. The informed consent form and ethic committee are necessary before the enrollment. 

排除标准:

(1)患者四周内曾参加过另外的药物临床实验;(2)一周内因营养不良输注过脂肪乳;(3)预期生命不长于7天者;(4)有肠外营养禁忌的患者,如凝血功能紊乱、难以纠正的代谢性疾病;(5)孕期或哺乳期患者;(6)潜在不合作或不遵从研究协议的患者;(7)严重心肺功能不全;(8)严重血脂紊乱,如甘油三酯或胆固醇超过上限的2倍水平;(9)肝功能明显异常,如AST等水平超过上限的3倍、重度胆汁淤积或结合胆红素水平超过上限的2倍;(10)慢性肾衰,如尿素氮和肌酐水平超过上限值的2倍;(11)对脂肪乳的成份或相似成份过敏者,如鸡蛋或大豆蛋白;(12)长期使用类固醇类或免疫抑制剂药物的患者;(13)术前行放疗或化疗的病人;(14)自身免疫疾病患者,如类风湿性关节炎、HIV、系统性红斑狼疮等;(15)三个月以内出现的可能对免疫系统损害的疾病,如慢性感染。 

Exclusion criteria:

(1) the patients have taken part in another drug cilincial trial in four weeks; (2) lipid emmusion have been infused for malnutrition in one week; (3) life expectancy less than seven days; (4) contraindication for parenteral nutrition (disturbance of blood coagulation ,unrightable Metabolic disease); (5) known in pregnancy or breastfeeding; (6) patients are potential uncooperative or dont obey the reseach protocol; (7) severe cardiopulmonary insufficiency; (8) severe dyslipdemia (Triglyceride or cholesterol levels are more than 2 times of the upper limit of normal); (9) liver dysfunction (AST level are more than 3 times the upper limit of normal, Severe cholestasis or Conjugated bilirubin level of are more than 2 times the upper limit of normal); (10) Chronic renal failure (the level of BUN and Creatinine exceed 2 times of the upper limit of normal); (11) be allergic to any ingredients or accessories of lipid emmusion(eg. Egg or soybean protein); (12) long history of corticosteroids and immunosuppressive agents; (13) History of preoperative radiotherapy or chemotherapy; (14) Long history of autoimmune disease (Rheumatoid arthritis HIV, SLE et al); (15) disease appears in three months, which have bad effect on the immune system,such as chronic infection. 

研究实施时间:

Study execute time:

From2013-09-05To 2014-03-05 

干预措施:

Interventions:

组别:

试验组

样本量:

47

Group:

Study group

Sample size:

干预措施:

全合一营养液中脂肪乳成分使用橄榄油脂肪乳(克林诺),其余成分相同

干预措施代码:

Intervention:

All-in-one bags,fat emulsion is olive-oil-based lipid emulsion (ClinOleic)

Intervention code:

组别:

对照组

样本量:

47

Group:

control group

Sample size:

干预措施:

全合一营养液中脂肪乳成分使用中长链脂肪乳(力保肪宁),其余成分相同

干预措施代码:

Intervention:

All-in-one bags,fat emulsion is LCT/MCT fat emulsion(Lipofundin)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shaanxi 

City:

Xi'an 

单位(医院):

唐都医院 

单位级别:

三级甲等医院 

Institution
hospital:

Tangdu Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学肿瘤防治中心 

单位级别:

三级甲等医院 

Institution
hospital:

Sun Yat-sen University Cancer center  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

临床结局

指标类型:

主要指标 

Outcome:

clinical outcome

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫功能

指标类型:

主要指标 

Outcome:

immune function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养参数

指标类型:

主要指标 

Outcome:

Nutrition parameter

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

主要指标 

Outcome:

liver and renal function tests

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖、血脂

指标类型:

主要指标 

Outcome:

blood glucose, cholesterol and triglycerides

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:

Sample Name:

Blood

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 70 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):

计算机软件

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

computer generated

盲法:

受试者 患者接受输液不知道是何种脂肪乳, 研究者 主管医师 不知道何种脂肪乳剂

Blinding:

physician and nurse: blinding patients: blinding

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

第四军医大学唐都医院

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

Tangdu Hospital ,The fourth military 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:

第四军医大学唐都医院

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

Tangdu Hospital ,The fourth military medical university

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-08-29
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