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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817685
• Other study ID #: SYSU2016
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: June 27, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: zhongzhen zz Su, doctor
• Phone: 0086-020-85252010
• Email: sp9313[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7660
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Other:
• 3 months

• 6 months

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

Locations

Country	Name	City	State
China	The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Hepatocellular carcinoma		3 year	No