Clinical trial NCT02817685: Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
Official title: Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: surveillance
hepatocellular carcinoma
ultrasound
cirrhosis
chronic hepatitis B
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 7660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Hepatitis B patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of Hepatocellular carcinoma
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
name: zhongzhen zz Su, doctor
role: STUDY_DIRECTOR
References: