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

This study has been completed.
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital Identifier:
First received: July 26, 2006
Last updated: December 2, 2013
Last verified: December 2013

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

Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: Transarterial chemoembolization
Procedure: Percutaneous ethanol injection therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • overall survival rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease free survival rate and recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: October 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chemotherapy
Transarterial chemoembolization (TACE)
Procedure: Transarterial chemoembolization
lipiodol, adriamycin and/or mitomycin
Other Name: TACE
Active Comparator: ethanol
Percutaneous ethanol injection therapy (PEIT)
Procedure: Percutaneous ethanol injection therapy
99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
Other Name: PEIT

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts 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)
  Contacts and Locations
Please refer to this study by its identifier: NCT00357474

Korea, Republic of
Seoul NUH
Seoul, Chongno-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: J H Yoon, Professor Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital Identifier: NCT00357474     History of Changes
Other Study ID Numbers: 07-2006-010
Study First Received: July 26, 2006
Last Updated: December 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents processed this record on April 16, 2014