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

This study has been completed.
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital Identifier:
First received: July 26, 2006
Last updated: December 2, 2013
Last verified: December 2013
The purpose of this study is to choose the preferred treatment modality for solitary, small hepatocellular carcinoma.

Condition Intervention Phase
Hepatocellular Carcinoma Procedure: Operation Procedure: Percutaneous ethanol injection therapy Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Jung-Hwan Yoon, Seoul National University Hospital:

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

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

Enrollment: 36
Study Start Date: October 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
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)
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital Identifier: NCT00357422     History of Changes
Other Study ID Numbers: 07-2007-006
Study First Received: July 26, 2006
Last Updated: December 2, 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 processed this record on August 17, 2017