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Prospective, multicenter, randomized, controlled clinical study of regional lymphotomy and extended lymphotomy in hilar cholangiocarcinoma
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注册号:

Registration number:

ChiCTR1800015688 

最近更新日期:

Date of Last Refreshed on:

2018-04-15 

注册时间:

Date of Registration:

2018-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肝门胆管癌区域淋巴清扫与扩大淋巴清扫前瞻性、多中心、随机对照临床研究 

Public title:

Prospective, multicenter, randomized, controlled clinical study of regional lymphotomy and extended lymphotomy in hilar cholangiocarcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肝门胆管癌区域淋巴清扫与扩大淋巴清扫前瞻性、多中心、随机对照临床研究 

Scientific title:

Prospective, multicenter, randomized, controlled clinical study of regional lymphotomy and extended lymphotomy in hilar cholangiocarcinoma 

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:

何敏 

研究负责人:

王坚 

Applicant:

Min He 

Study leader:

Jian Wang 

申请注册联系人电话:

Applicant telephone:

+86 13917019110 

研究负责人电话:

Study leader's telephone:

+86 13917019110 

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:

shirley0815@126.com 

研究负责人电子邮件:

Study leader's E-mail:

shirley0815@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:

上海市浦建路160号 

研究负责人通讯地址:

上海市浦建路160号 

Applicant address:

160 Pujian Road, Shanghai, China 

Study leader's address:

160 Pujian Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200127 

研究负责人邮政编码:

Study leader's postcode:

200127 

申请人所在单位:

上海交通大学医学院附属仁济医院 

Applicant's institution:

Renji Hospital Affiliated to Medical School, Shanghai Jiaotong 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:

上海交通大学医学院附属仁济医院 

Primary sponsor:

Renji Hospital Affiliated to Medical School, Shanghai Jiaotong University 

研究实施负责(组长)单位地址:

上海市浦建路160号 

Primary sponsor's address:

160 Pujian Road, 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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属仁济医院

具体地址:

上海市浦建路160号

Institution
hospital:

Renji Hospital Affiliated to Medical School, Shanghai Jiaotong University

Address:

160 Pujian Road, Shanghai, China

经费或物资来源:

上海交通大学医学院多中心临床研究课题 

Source(s) of funding:

Multicenter Clinical study of School of Medicine of Shanghai Jiaotong University 

研究疾病:

肝门胆管癌 

Target disease:

hilar cholangiocarcinoma 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1.评估肝门胆管癌切除术中扩大淋巴结清扫的临床安全性 2.评估不同淋巴结清扫范围对患者生存期的影响 

Objectives of Study:

1. Evaluation of clinical safety of enlarged lymph node dissection in hilar cholangiocarcinoma resection; 2. Evaluation of the effect of different lymph node dissection on survival of patients. 

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)年龄>18岁,并且≤80岁的患者; 2)诊断为肝门胆管癌(影像学、实验室检验、术中冰冻),术后病理确诊为胆管肿瘤; 3)肿瘤能被完整切除(R0); 4)患者有自主能力,理解并自愿签署书面知情同意书并且能够完成随访计划; 5)孕龄女性患者需排除在孕; 6)肝功能Child-Turcotte-Pugh评分A-B级, 血清胆红素 ≤正常值上限1.5倍,ALT、AST ≤ 正常值上限2倍;肌酐清除率≥60ml/min;血红蛋白≥90g/L; 7)ASA1-4; 8)试验筛查前签署书面知情同意书。 

Inclusion criteria

1) patients aged 18 to 80 years old; 2) diagnosis of hilar cholangiocarcinoma (imaging, laboratory examination, intraoperative frozen, postoperative pathological diagnosis of cholangiocarcinoma; 3) the tumor can be removed completely; 4) the patient is autonomous, understands and voluntarily signs written informed consent and is able to complete the follow-up plan; 5) pregnant women should be excluded from pregnancy; 6) Child-Turcotte-Pugh score of liver function A-B, the upper limit of serum bilirubin ≤ normal value is 1.5 times and the upper limit of alt AST ≤ normal value is 2 times; Anhydride clearance ≥ 60ml / min, hemoglobin ≥ 90g / L; ASA 1-4; 7) sign written informed consent before screening. 

排除标准:

1)肿瘤R1切除; 2)患者具有影响胆管癌处理的明显的心、肺、脑、肾功能不全; 3)患者有其他恶性肿瘤病史; 4)肝功能Child-Turcotte-Pugh评分C级; 5)怀孕或者正处在哺乳期的女性患者 6)研究者判定不适合参加本研究者。 

Exclusion criteria:

1) resection of tumor R1; 2) the patients had significant heart, lung, brain and renal dysfunction affecting the management of cholangiocarcinoma; 3) the patient has other malignant tumor history; 4) Child-Turcotte-Pugh grade C of liver function; 5) Women who are pregnant or are breastfeeding; 6) the researcher decided that he was not fit to participate in this study. 

研究实施时间:

Study execute time:

From2018-06-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2018-06-01To 2023-12-31 

干预措施:

Interventions:

组别:

1

样本量:

200

Group:

1

Sample size:

干预措施:

肝门胆管癌切除术区域淋巴结清扫(8a/p, 12a/b/c/h/p,13a)

干预措施代码:

Intervention:

Regional resection of hilar cholangiocarcinoma (8a/p, 12a/b/c/h/p, 13a).

Intervention code:

组别:

2

样本量:

200

Group:

2

Sample size:

干预措施:

肝门胆管癌切除术扩大淋巴结清扫(8a/p, 9,12a/b/c/h/p,13a, 14, 16)

干预措施代码:

Intervention:

Hilar cholangiocarcinoma resection and extended lymph node dissection (8a/p, 9,12a/b/c/h/p, 13a, 14, 16).

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仁济医院 

单位级别:

三级甲等医院 

Institution
hospital:

Renji Hospital Affiliated to Medical School, Shanghai Jiaotong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

生存期

指标类型:

主要指标 

Outcome:

Overall survival

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:

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 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,单盲,随机数字表法

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

Random, single blind, random digital table method

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

2025年12月,网络平台(www.chictr.org.cn)

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

2025.12,internet(www.chictr.org.cn)

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:

数据的可溯源性、病例报告表(CRF)的填写 本研究数据管理由研究者负责,需确保临床试验数据的真实性,完整性和私密性。保证临床试验数据的可溯源性。病例报告表由研究者或者研究者指定人员参照原始病例如实填写,不得随意涂改。如需要修改应按照CRF填写说明进行规范操作,并签署修改者姓名及修改日期。研究者需对每本CRF信息进行核实,确保其准确及真实性,并签署姓名及核实日期。 数据核查 数据核查包括计算机化的程序核查,人工核查以及数据核查会议。对核查中发现的不一致数据应及时更正,递交研究者确认后作出更改。

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

Traceability of data, completion of case report form CRFData management in this study is the responsibility of researchers to ensure the authenticity, integrity and privacy of clinical trial data.Ensure traceability of clinical trial data.The case report form shall be filled in according to the facts of the original case by the researcher or the person appointed by the researcher, and shall not be altered at will.If necessary, follow the CRF instructions and sign the name and date of the modification.The researcher is required to verify each CRF information to ensure its accuracy and authenticity, and to sign the name and date of verification.Data verificationData verification includes computers Meetings on program verification, manual verification and data verification.The inconsistent data found in the verification should be corrected in time and submitted to the researcher for confirmation.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-04-15
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