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Long-term follow-up outcomes of regarding the cumulative incidence of Hepatocellularhepatocellular carcinoma in among 362 patients with chronic hepatitis B without antiviral therapy
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注册号:

Registration number:

ChiCTR2000029281 

最近更新日期:

Date of Last Refreshed on:

2020-01-20 

注册时间:

Date of Registration:

2020-01-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

362例未经抗病毒治疗的慢性乙型肝炎患者肝癌累积发生率长期随访结局 

Public title:

Long-term follow-up outcomes of regarding the cumulative incidence of Hepatocellularhepatocellular carcinoma in among 362 patients with chronic hepatitis B without antiviral therapy  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

抗炎保肝与抗病毒对慢性乙型肝炎患者肝癌发生率长期随访研究 

Scientific title:

Long-term follow-up study of anti-inflammatory liver-protection and anti-viral on the incidence of liver cancer in patients with chronic hepatitis B 

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:

童光东 

研究负责人:

姜小艳 

Applicant:

Tong Guangdong 

Study leader:

Jiang Xiaoyan 

申请注册联系人电话:

Applicant telephone:

+86 13603028208 

研究负责人电话:

Study leader's telephone:

+86 13662291956 

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:

tgd755@163.com 

研究负责人电子邮件:

Study leader's E-mail:

767463255@qq.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:

深圳市福田区福华路1号 

研究负责人通讯地址:

深圳市福田区福华路1号 

Applicant address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, 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:

深圳市中医院 

Applicant's institution:

Shenzhen Traditional Chinese Medicine Hospital 

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:

深中医伦审(研){2008}1 

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:

深圳市中医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shenzhen Traditional Chinese Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

于枫 

Contact Name of the ethic committee:

Yu Feng 

伦理委员会联系地址:

深圳市福田区福华路1号 

Contact Address of the ethic committee:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, 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:

深圳市中医院 

Primary sponsor:

Shenzhen Traditional Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

深圳市福田区福华路1号 

Primary sponsor's address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

深圳市中医院

具体地址:

深圳市福田区福华路1号

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital

Address:

1 Fuhua Road, Futian District, Shenzhen

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

慢性乙型病毒性肝炎 

Target disease:

Chronic hepatitis B 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

观察未经抗病毒治疗的慢性乙型肝炎(CHB)患者长期随访的结局 

Objectives of Study:

To observe the outcomes of the long-term follow-up of patients with chronic hepatitis B (CHB) without antiviral treatment 

药物成份或治疗方案详述:

根据纳入标准及排除标准,收集了1993年1月-1998年12月期间在我科住院治疗的362例CHB患者及96例乙肝肝硬化患者,均具有抗病毒治疗指针,但因各种原因未接受抗病毒治疗,仅用抗炎保肝药物,作为观察组,中位随访时间分别为10年、7年;以接受抗病毒的203例CHB及129例乙肝肝硬化患者为抗病毒治疗组,中位数随访时间分别为8年、7年。对这些患者每6个月随访一次,检测肝功能、HBVDNA、HBV血清标志物、AFP及B超等。定量资料采用非参数检验,定性资料采用卡方检验。采用Kaplan Meier分析肝癌累积发生率,COX回归模型分析肝癌发生的危险因素。 

Description for medicine or protocol of treatment in detail:

This study included 362 of patients with CHB and 96 of with hepatitis B cirrhosis patients, without antiviral treatment and, with only liver protection and anti-inflammatory treatment in from 1993–1998 was identified. .The median follow-up peroid times was were 10 years and 7 years, respectively. A total of 203 of CHB and 129 of hepatitis B cirrhosis patients receiving antiviral therapy were selected as the control groups. MedianThe median follow-up period times was were 8 years and 7 years, respectively. Kaplan MeierKaplan-Meier curves was were used to analyze the cumulative incidence of Hepatocellularhepatocellular carcinoma (HCC), and the CoxOX regression model was used to analyze the risk factors of HCC. 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

慢性乙型肝炎(没有肝硬化): (1)HBsAg阳性至少持续6个月; (2)年龄18-75岁; (3)未使用干扰素治疗; (4)抗炎保肝患者,ALT≥2ULN,HBV DNA阳性,随访时间≥2年; (5)抗病毒患者:自愿接受核苷类抗病毒治疗,并随访时间≥2年,且接受抗炎保肝治疗时间≤6个月。 乙肝肝硬化: 患者入组时,影像学或组织学明确诊断为乙肝肝硬化代偿期,其中Child-Turcotte-Pugh(CTP)积分》7分诊断失代偿期。 

Inclusion criteria

Chronic hepatitis B patients(no cirrhosis): (1) HBsAg positive for at least 6 months; (2) aged 18-75 years; (3) no interferon treatment; (4) Patients who just received Anti-inflammatory and liver-protecting therapy, ALT >=2 ULN, HBV DNA positive, follow-up time >=2 years; (5) anti-viral patients: voluntary nucleoside antiviral therapy, and follow-up time >=2 years, the time of Anti-inflammatory and liver-protecting treatment <=6 months. Hepatitis B cirrhosis patients: Patients with a clear diagnosis of hepatitis B cirrhosis by imaging or histology at the time of enrollment, Child-Turcotte-Pugh (CTP) scores >=7 points were diagnosed as decompensated for hepatitis B cirrhosis. 

排除标准:

排除标准:(1)慢性乙型肝炎合并药物性肝损害,酒精性肝病,自身免疫性肝病等其他肝脏疾病的患者;(2)肝细胞癌患者;(3)治疗后1年内,发生肝癌的患者;(4)抗炎保肝患者抗炎保肝治疗随访少于2年;(5)抗病毒组患者抗病毒治疗随访时间少于2年,抗炎保肝治疗时间大于6个月。 

Exclusion criteria:

(1) patients with chronic hepatitis B complicated with drug-induced liver damage, alcoholic liver disease, autoimmune liver disease and other liver diseases; (2) patients with hepatocellular carcinoma; (3) liver cancer occurred within 1 year after treatment; (4) follow-up time of anti-inflammatory and liver-protecting patients less than 2 years; (5) follow-up time of anti-viral patients less than 2 years, anti-inflammatory and liver-protecting treatment time more than 6 months. 

研究实施时间:

Study execute time:

From2009-01-01To 2019-01-01 

干预措施:

Interventions:

组别:

Case series

样本量:

790

Group:

Case series

Sample size:

干预措施:

本研究不属于干预性研究

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市中医院 

单位级别:

三甲医院 

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肝癌

指标类型:

主要指标 

Outcome:

hcc

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 years
最大 Max age 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):

本研究未采用随机

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

This study did not use random

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

ResMan临床试验公共管理平台

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

ResMan (www.medresman.org)

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:

Excel

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

Excel

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-01-20
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