Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication

Completed

• Conditions: Hepatocellular Carcinoma; Hepatitis B Virus

• Registration Number: NCT00769730
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy.This study is to investigate the possibility of TACE in the reactivation of hepatitis B virus.

Detailed Description

Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Chronic hepatitis B infection is the common etiology for the development of HCC. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy. There is no study to investigate the possibility of TACE in the reactivation of hepatitis B virus. This project will collect 20 patients with HCC caused by hepatitis B who are planned to be treated by TACE. Quantitative determination of viral load in blood will be performed before TACE, the first and the third month after TACE to investigate the influence of TACE on hepatitis B virus replication. This study will not influence the doctor's decision in the management of HCC and the procedure of TACE. The serum used for HBV DNA examination is concomitantly obtained during regular blood sampling for TACE preparation and follow-up of patient. The amount of blood needed for each time HBV DNA examination is less than 10 ml.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-08-02
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients with hepatocellular carcinoma caused by hepatitis B virus without antiviral drug treatment and patients will be treated by transcatheter arterial chemoembolization

Exclusion Criteria

• patients already received antiviral drug management

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HBV viral load	3 months

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan