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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00357422
First received: July 26, 2006
Last updated: December 2, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


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 ]

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 2, 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
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014