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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT00357422
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
overall survival rate	5 year

Secondary Outcome Measures

Name	Time	Method
disease free survival rate and recurrence rate	5 year

Trial Locations

Locations (1)

Seoul NUH; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of