Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357422
• Other study ID #: 07-2007-006
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: July 2011

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:

1. Survival

• 5 year overall survival rate

• Disease free survival rate

2. Recurrence

• Cumulative recurrence rate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• The evidences of hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis

• Single tumor nodule with Child-Pugh classification A (serum albumin = 3.2 g/dL)

• The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm

• Only for the newly detected HCCs which were not treated before

• It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI)

• Without portal hypertension

Exclusion Criteria:

• In case of hepatic vein or portal vein invasion radiologically (CT or MRI)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Operation
No drug needed
• 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
Secondary	disease free survival rate and recurrence rate		5 year