Trial Information
A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival rate
Outcome Time Frame:
5 year
Safety Issue:
Yes
Principal Investigator
J H Yoon, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
07-2006-010
NCT ID:
NCT00357474
Start Date:
October 2005
Completion Date:
April 2013
Related Keywords:
- Hepatocellular Carcinoma
- HCC, TACE, PEIT
- Carcinoma
- Carcinoma, Hepatocellular