- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817685
Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surveillance of chronic hepatitis B and cirrhotic patients had been demonstrated to increase chances of curative treatment for hepatocellular carcinoma. However, the optimal surveillance interval for different risk patients is still controversial. The AASLD and EASL-EORTC guidelines recommend chronic hepatitis B patients undergoing ultrasound surveillance at a time interval of 6 months, but the Japanese HCC guideline recommend the very-high risk patients undergoing ultrasound surveillance at a time interval of 3 or 4 months.
The incidence of HCC is 0.3%-0.8% in the chronic hepatitis B patients and 2%-8% in cirrhotic patients, thus recalling a different follow-up strategy for different stage of chronic hepatitis B patients. Besides, ultrasound is the admitted surveillance tool for HCC for its convenience and cost-effectiveness. However, the sensitivity of ultrasound detecting HCC will remarkably decrease because of the influence of ribs, pulmonary and gastrointestinal gas, cirrhosis and fatty liver. So it is necessary to incorporate computed tomography (CT) or magnetic resonance imaging (MRI) into the follow-up strategy of very high risk patient such as patients with cirrhosis or history of HCC.
The aim of this study is to investigate whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC, ultimately establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of HCC.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zhongzhen zz Su, doctor
- Phone Number: 0086-020-85252010
- Email: sp9313@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
-
Contact:
- Zhongzhen zz Su, doctor
- Phone Number: 0086-020-85252010
- Email: sp9313@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HBV-Ag positive( >6 months)
- age among 18 and 80 years
Exclusion Criteria:
- patients with hepatocellular carcinoma
- patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
- patients with alcoholic hepatitis or autoimmune hepatitis
- patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
- coinfection with human immunodeficiency virus(HIV)
- cannot undergo contrast-enhanced imaging
- refuse attending the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Chronic Hepatitis B patient
|
|
2
Chronic Hepatitis B patient
|
|
3
cirrhotic patient
|
|
4
cirrhotic patient
|
|
5
ultrasound-difficult patient
|
|
6
ultrasound-difficult patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of Hepatocellular carcinoma
Time Frame: 3 year
|
3 year
|
Collaborators and Investigators
Investigators
- Study Director: zhongzhen zz Su, doctor, The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Liver Neoplasms
- Enterovirus Infections
- Picornaviridae Infections
- Carcinoma
- Hepatitis B
- Hepatitis
- Carcinoma, Hepatocellular
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- SYSU2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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