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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial chemoembolization; Procedure: Percutaneous ethanol injection therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00357474

07-2006-010

Details and patient eligibility

About

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

Full 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

Enrollment: 22 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

chemotherapy

Active Comparator group

Description:

Transarterial chemoembolization (TACE)

Treatment:

Procedure: Transarterial chemoembolization

ethanol

Active Comparator group

Description:

Percutaneous ethanol injection therapy (PEIT)

Treatment:

Procedure: Percutaneous ethanol injection therapy