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Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)

Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00357422
Enrollment
36
Registered
2006-07-27
Start date
2005-10-31
Completion date
2011-07-31
Last updated
2018-09-10

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

Conditions

Hepatocellular Carcinoma

Keywords

HCC, operation, percutaneous ethanol injection

Brief summary

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

Detailed description

To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group: 1. Survival * 5 year overall survival rate * Disease free survival rate 2. Recurrence * Cumulative recurrence rate

Interventions

PROCEDUREOperation

No drug needed

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 hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis * Single tumor nodule with Child-Pugh classification A (serum albumin ≥ 3.2 g/dL) * The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm * Only for the newly detected HCCs which were not treated before * It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI) * Without portal hypertension

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