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

Sun Yat-sen University

Status: Unknown

Conditions: Chronic Hepatitis B

Treatments: Other: 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI; Other: 3 months; Other: 6 months

Study type: Observational

Funder types: Other

Identifiers

NCT02817685

SYSU2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,660 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

7,660 participants in 6 patient groups

1

Description:

Chronic Hepatitis B patient

Treatment:

Other: 3 months

2

Description:

Chronic Hepatitis B patient

Treatment:

Other: 6 months

3

Description:

cirrhotic patient

Treatment:

Other: 3 months

4

Description:

cirrhotic patient

Treatment:

Other: 6 months

5

Description:

ultrasound-difficult patient

Treatment:

Other: 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI

6

Description:

ultrasound-difficult patient

Treatment:

Other: 6 months