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

Seoul National University Hospital36 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

OperationPROCEDURE

No drug needed

Percutaneous ethanol injection therapyPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul NUH

Seoul, Chongno-gu, South Korea

Outcomes

Primary Outcomes

overall survival rate

Time frame: 5 year

Secondary Outcomes

disease free survival rate and recurrence rate

Time frame: 5 year

Data from ClinicalTrials.gov

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