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

A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00357474
Enrollment
22
Registered
2006-07-27
Start date
2005-10-31
Completion date
2012-02-29
Last updated
2013-12-04

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

Conditions

Hepatocellular Carcinoma

Keywords

HCC, TACE, PEIT

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

Interventions

PROCEDURETransarterial chemoembolization

lipiodol, adriamycin and/or mitomycin

99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
overall survival rate5 year

Secondary

MeasureTime frame
Disease free survival rate and recurrence rate5 year

Countries

South Korea

Outcome results

None listed

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