今天是:2020-08-03 星期一

充气纵隔镜联合腹腔镜vs胸腔镜联合腹腔镜 食管癌切除术的安全性和有效性的对比研究—一项多中心临床随机对照研究
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注册号:

Registration number:

ChiCTR2000029351 

最近更新日期:

Date of Last Refreshed on:

2020-01-25 

注册时间:

Date of Registration:

2020-01-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

充气纵隔镜联合腹腔镜vs胸腔镜联合腹腔镜 食管癌切除术的安全性和有效性的对比研究—一项多中心临床随机对照研究 

Public title:

Comparative study on the safety and effectiveness of inflatable mediastinoscopy combined with laparoscopy vs thoracoscopy combined with laparoscopy for esophageal cancer resection—a multicenter randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

充气纵隔镜联合腹腔镜vs胸腔镜联合腹腔镜 食管癌切除术的安全性和有效性的对比研究—一项多中心临床随机对照研究 

Scientific title:

Comparative study on the safety and effectiveness of inflatable mediastinoscopy combined with laparoscopy vs thoracoscopy combined with laparoscopy for esophageal cancer resection—a multicenter randomized controlled trial 

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:

胡杨 

研究负责人:

胡杨 

Applicant:

Yang Hu 

Study leader:

Yang Hu 

申请注册联系人电话:

Applicant telephone:

+86 28-85422494 

研究负责人电话:

Study leader's telephone:

+86 28-85422494 

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:

huyangthoracic@126.com 

研究负责人电子邮件:

Study leader's E-mail:

huyangthoracic@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:

成都市国学巷37号 

研究负责人通讯地址:

成都市国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan Province, China. 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan Province, China. 

申请注册联系人邮政编码:

Applicant postcode:

610000 

研究负责人邮政编码:

Study leader's postcode:

610000 

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:

816 

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委员会 

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:

2019-11-05 

伦理委员会联系人:

刘伦旭 

Contact Name of the ethic committee:

Lunxu Liu 

伦理委员会联系地址:

成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan Province, China. 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 28-85422494 

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, Sichuan University 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District

国家:

日本

省(直辖市):

京都市

市(区县):

Country:

Japan

Province:

Kyoto

City:

单位(医院):

京都府立医科大学

具体地址:

日本京都市

Institution
hospital:

Kyoto Prefectural University of Medicine

Address:

Kyoto, JAPAN

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市肿瘤医院

具体地址:

沙坪坝区汉渝路181号

Institution
hospital:

Chongqing Cancer Hospital

Address:

181 Hanyu Road, Shapingba District

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 附属肿瘤医院

具体地址:

东风东路651号

Institution
hospital:

Sun Yat-Sen University Cancer Center

Address:

651 Dongfeng Road East

国家:

中国

省(直辖市):

武汉

市(区县):

武汉

Country:

China

Province:

Wuhan

City:

Wuhan

单位(医院):

武汉协和同济医院

具体地址:

江汉区解放大道1277号

Institution
hospital:

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Address:

1277 Jiefang Avenue, Jianghan District

国家:

中国

省(直辖市):

四川

市(区县):

南充

Country:

China

Province:

Sichuan

City:

Nanchong

单位(医院):

川北医学院附属医院

具体地址:

顺庆区文化路63号

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College

Address:

63 Wenhua Road, Shunqing District

经费或物资来源:

四川大学华西医院临床研究孵化项目 

Source(s) of funding:

Clinical Research Incubation Project of West China Hospital, Sichuan University 

研究疾病:

食管癌 

Target disease:

Esophageal 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:

充气纵隔镜联合腹腔镜食管癌手术是近年新出现的食管癌手术方式,因其较目前通用的胸腔镜联合腹腔镜食管癌切除术更有微创的优势而极具发展的潜力。本研究旨在比较食管癌患者行充气纵隔镜与胸腔镜食管切除术手术的有效性和安全性。 

Objectives of Study:

Inflatable mediastinoscopy combined with laparoscopic esophageal cancer surgery is a new surgical approach to esophageal cancer in recent years. It has a minimally invasive advantage and currently has great potential for development compared with the current general use of thoracoscopy combined with laparoscopic esophageal cancer resection. The purpose of this study was to compare the effectiveness and safety of inflatable mediastinoscopy and thoracoscopy esophagectomy in patients with esophageal cancer. 

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 能理解本研究的程序和方法,愿意严格遵守试验方案完成本试验,并自愿签署知情同意书; ② 年龄在45-75岁之间; ③ 临床诊断或病理确诊为食管癌且拟行腔镜食管癌根治术的手术患者; ④ 既往未曾接受食管癌手术; ⑤ 食管癌手术治疗前的相关毒性已恢复,器官功能水平符合下列要求: 1)外周血细胞计数:白细胞计数≥ 3×10^9/L且中性粒细胞≥ 1.5×10^9/L,血 小板计数≥ 75×10^9/L,血红蛋白≥ 8 g/dL; 2)肝功能:总胆红素≤ 1.5倍正常参考值上限;AST和ALT ≤ 2.5倍正常参考值上限;存在肝转移灶的受试者,总胆红素应≤ 2.5倍正常参考值上限,AST和ALT应≤ 5倍正常参考值上限; 3)肾功能:血清肌酐≤ 1.5倍正常参考值上限。 

Inclusion criteria

1. Can understand the procedures and methods of this research, is willing to strictly follow the test plan to complete this test, and voluntarily sign the informed consent; 2. Aged 45-75 years; 3. Surgery patients with clinical diagnosis or pathological diagnosis of esophageal cancer who plan to undergo radical laparoscopic esophageal cancer surgery; 4. Have not undergone esophageal cancer surgery before; 5. The related toxicity before esophageal cancer surgery has recovered, and the level of organ function meets the following requirements: 1) Peripheral blood cell count: white blood cell count >= 3 x 10^9 / L and neutrophils >= 1.5 x 10^9 / L, blood platelet count >= 75 x 10^9 / L, hemoglobin >= 8 g / dL; 2) Liver function: total bilirubin <= 1.5 times the upper limit of normal reference value; AST and ALT <= 2.5 times the upper limit of normal reference value; in subjects with liver metastases, total bilirubin should be <= 2.5 times the upper limit of normal reference value, AST and ALT should be <= 5 times the upper limit of the normal reference value; 3) Renal function: serum creatinine <= 1.5 times the upper limit of normal reference value. 

排除标准:

1. 入院前1月内有激素雾化吸入或全身激素应用史; 2. 近期内心梗、心衰、神经肌肉类疾病等; 3. 其他呼吸训练相关禁忌; 4. 术中发生出血>1000ml、中转开胸等; 5. HIV感染或活动性乙型肝炎或丙型肝炎; 6. 存在凝血功能障碍的患者; 7. 既往有明确的神经或精神障碍史,包括癫痫或痴呆; 8. 研究者认为患者可能存在影响本研究的疗效或安全性评价的其他因素。 

Exclusion criteria:

1. History of hormone atomization or systemic hormone application within 1 month before admission; 2. Recent myocardial infarction, heart failure, neuromuscular diseases, etc .; 3. Other contraindications related to breathing training; 4. Bleeding during operation > 1000ml, transfer to open chest, etc .; 5. HIV infection or active hepatitis B or C; 6. Patients with coagulopathy; 7. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 8. Researchers believe that patients may have other factors affecting the efficacy or safety evaluation of this study. 

研究实施时间:

Study execute time:

From2020-03-01To 2024-12-31 

征募观察对象时间:

Recruiting time:

From2020-03-01To 2024-06-30 

干预措施:

Interventions:

组别:

Group 1

样本量:

112

Group:

Group 1

Sample size:

干预措施:

充气纵膈镜食管癌切除术

干预措施代码:

Intervention:

Esophageal cancer resection of inflatable mediastinoscopy combined with laparoscopy

Intervention code:

组别:

Group 2

样本量:

112

Group:

Group 2

Sample size:

干预措施:

胸腹腔镜食管癌切除术

干预措施代码:

Intervention:

Esophageal cancer resection of thoracoscopy combined with laparoscopy

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, Sichuan University  

Level of the institution:

Tertiary A 

国家:

日本 

省(直辖市):

京都 

市(区县):

 

Country:

Japan 

Province:

Kyoto 

City:

 

单位(医院):

京都府立医科大学 

单位级别:

三级 

Institution
hospital:

Kyoto Prefectural University of Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Chongqing Cancer Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Sun Yat-Sen University Cancer Center  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

武汉 

市(区县):

 

Country:

China 

Province:

Wuhan 

City:

 

单位(医院):

武汉协和同济医院 

单位级别:

三甲 

Institution
hospital:

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

川北医学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

从食管癌患者完成手术后开始至食管癌复发或死亡的时间

指标类型:

主要指标 

Outcome:

DFS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

从随机化开始至因任何原因引起受试者死亡的时间

指标类型:

次要指标 

Outcome:

OS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评估

指标类型:

次要指标 

Outcome:

assessment of safety

Type:

Secondary 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 75 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):

本试验采用分层区组随机方法,分层因素为:性别。由统计师用R软件blockrand软件包根据给定种子数,按照试验组与对照组1:1的比例,生成受试者随机分配表,试验组与对照组分别产生随机号240个,共计480个。所有受试者在符合入组标准筛选合格后,研究者或指定人员根据性别和研究中心,按照筛选好号大小依次获得随机号。

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

This experiment uses a stratified block random method, and the stratification factor is gender. The statistician used the R software blockrand software package to generate a random distribution table of subjects according to a given number of seeds and a ratio of 1:1.

盲法:

Not stated

Blinding:

Not stated

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):

Epidata

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

Epidata

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:

Epidata

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

Epidata

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-25
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