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

July 26, 2006
April 16, 2013
October 2005
April 2013   (final data collection date for primary outcome measure)
overall survival rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
5 year overall survival rate
Complete list of historical versions of study NCT00357474 on ClinicalTrials.gov Archive Site
Disease free survival rate and recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
Disease free survival rate and recurrence rate
Not Provided
Not Provided
 
Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs
A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Procedure: Transarterial chemoembolization
    lipiodol, adriamycin and/or mitomycin
    Other Name: TACE
  • 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
  • Active Comparator: chemotherapy
    Transarterial chemoembolization (TACE)
    Intervention: Procedure: Transarterial chemoembolization
  • Active Comparator: ethanol
    Percutaneous ethanol injection therapy (PEIT)
    Intervention: Procedure: Percutaneous ethanol injection therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
April 2013
April 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00357474
07-2006-010
Yes
Jung-Hwan Yoon, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: J H Yoon, Professor Seoul National University Hospital
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP