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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00357474
First received: July 26, 2006
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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.

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: 284
Study Start Date: October 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00357474

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

No publications provided

Responsible Party: Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00357474     History of Changes
Other Study ID Numbers: 07-2006-010
Study First Received: July 26, 2006
Last Updated: April 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
HCC, TACE, PEIT

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

ClinicalTrials.gov processed this record on May 16, 2013