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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00769730
Enrollment
25
Registered
2008-10-09
Start date
2008-01-31
Completion date
2009-02-28
Last updated
2009-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus, Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, hepatitis B virus, transcatheter arterial chemoembolization

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.

Interventions

None listed

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HBV viral load3 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026