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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00357474
First received: July 26, 2006
Last updated: December 2, 2013
Last verified: December 2013
  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.

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Professor, 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: December 2, 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 August 20, 2014