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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357422
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Operation Procedure: Percutaneous ethanol injection therapy Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy
Study Start Date : October 2005
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Active Comparator: surgery Procedure: Operation
No drug needed
Other Name: surgery

Active Comparator: local therapy 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

Primary Outcome Measures :
  1. overall survival rate [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. disease free survival rate and recurrence rate [ Time Frame: 5 year ]

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357422

Korea, Republic of
Seoul NUH
Seoul, Chongno-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: J H Yoon, Professor Seoul National University Hospital

Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital Identifier: NCT00357422     History of Changes
Other Study ID Numbers: 07-2007-006
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
HCC, operation, percutaneous ethanol injection

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs