Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00357422
First received: July 26, 2006
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Seoul National University Hospital:

Primary Outcome Measures:
  • overall survival rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • disease free survival rate and recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 206
Study Start Date: October 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357422

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

No publications provided

Responsible Party: Jung Hwan Yoon/professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00357422     History of Changes
Other Study ID Numbers: 07-2007-006
Study First Received: July 26, 2006
Last Updated: April 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
HCC, operation, percutaneous ethanol injection

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

ClinicalTrials.gov processed this record on May 16, 2013