Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Transarterial chemoembolization; Procedure: Percutaneous ethanol injection therapy

• Registration Number: NCT00357474
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

Detailed Description

To compare the below things between PEIT group and TACE group

1. Survival

1. 5 year overall survival rate

2. Disease free survival rate

2. Recurrence a. recurrence rate

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis
• Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
• The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
• 1. Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
• It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion Criteria

• In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
chemotherapy	Transarterial chemoembolization	Transarterial chemoembolization (TACE)
ethanol	Percutaneous ethanol injection therapy	Percutaneous ethanol injection therapy (PEIT)

Primary Outcome Measures

Name	Time	Method
overall survival rate	5 year

Secondary Outcome Measures

Name	Time	Method
Disease free survival rate and recurrence rate	5 year

Trial Locations

Locations (1)

Seoul NUH; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of