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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Chronic Hepatitis B patient |
| |
| 2 | Chronic Hepatitis B patient |
| |
| 3 | cirrhotic patient |
| |
| 4 | cirrhotic patient |
| |
| 5 | ultrasound-difficult patient |
| |
| 6 | ultrasound-difficult patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 months | Other |
| ||
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Hepatocellular carcinoma | 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Hepatitis B patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhongzhen zz Su, doctor | Contact | 0086-020-85252010 | sp9313@126.com |
| Name | Affiliation | Role |
|---|---|---|
| zhongzhen zz Su, doctor | The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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|
| 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI | Other |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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