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

Seoul National University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Operation; Procedure: Percutaneous ethanol injection therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00357422

07-2007-006

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

surgery

Active Comparator group

Treatment:

Procedure: Operation

local therapy

Active Comparator group

Treatment:

Procedure: Percutaneous ethanol injection therapy