Comparison Study of Operation and Percutaneous Ethanol Injection Therapy for Small, Solitary Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.

Verified by Seoul National University Hospital, October 2008

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00357422

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 III

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
surgery: Active Comparator	Procedure: Operation No drug needed
local therapy: Active Comparator	Procedure: Percutaneous ethanol injection therapy 99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week

Detailed Description:

To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:

Survival
- 5 year overall survival rate
- Disease free survival rate
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 HBV(+) &/or 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 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

Contacts

Contact: J H Yoon, Professor

82 2 2072 2228

yoonjh@snu.ac.kr

Locations

Korea, Republic of, Chongno-gu
Seoul NUH	Recruiting
Seoul, Chongno-gu, Korea, Republic of, 110-744
Contact: J H Yoon, Professor 82 2 2072 2228 yoonjh@snu.ac.kr

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

J H Yoon, Professor

Seoul National University Hospital

More Information

Responsible Party:	Seoul National University Hospital ( Won Kim )
Study ID Numbers:	07-2007-006
Study First Received:	July 26, 2006
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00357422
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

HCC, operation, percutaneous ethanol injection

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Ethanol
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009