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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02817685

Enrollment

7660

Registered

2016-06-29

Start date

2016-05-31

Completion date

Unknown

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

surveillance, hepatocellular carcinoma, ultrasound, cirrhosis, chronic hepatitis B

Brief summary

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.

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.

Interventions

OTHER3 months

OTHER6 months

OTHER3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The incidence of Hepatocellular carcinoma	3 year

Countries

China

Contacts

Primary Contactzhongzhen zz Su, doctor

sp9313@126.com0086-020-85252010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026