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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357474
• Other study ID #: 07-2006-010
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: December 2, 2013
• Start date: October 2005
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Transarterial chemoembolization
lipiodol, adriamycin and/or mitomycin
• Percutaneous ethanol injection therapy
99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week

Locations

Country	Name	City	State
Korea, Republic of	Seoul NUH	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival rate		5 year	Yes
Secondary	Disease free survival rate and recurrence rate		5 year	Yes