Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial

June 27, 2016 updated by: Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University
This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.

Study Overview

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

Observational

Enrollment (Anticipated)

7660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic Hepatitis B patients

Description

Inclusion Criteria:

  1. HBV-Ag positive( >6 months)
  2. age among 18 and 80 years

Exclusion Criteria:

  1. patients with hepatocellular carcinoma
  2. patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
  3. patients with alcoholic hepatitis or autoimmune hepatitis
  4. patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
  5. coinfection with human immunodeficiency virus(HIV)
  6. cannot undergo contrast-enhanced imaging
  7. refuse attending the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: zhongzhen zz Su, doctor, The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

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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