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Sponsored by: |
Seoul National University Hospital |
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Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00357474 |
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Procedure: Transarterial chemoembolization Procedure: Percutaneous ethanol injection therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy. |
Estimated Enrollment: | 284 |
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 |
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1: Active Comparator
TACE
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Procedure: Transarterial chemoembolization
lipiodol, adriamycin and/or mitomycin
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2: Active Comparator
PEIT
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Procedure: Percutaneous ethanol injection therapy
99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
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To compare the below things between PEIT group and TACE group
Survival
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: H S Lee, professor | 82 2 2072 2228 | hsleemd@snu.ac.kr |
Korea, Republic of, Chongno-gu | |
Seoul NUH | Recruiting |
Seoul, Chongno-gu, Korea, Republic of, 110-744 | |
Contact: J H Yoon, Professor 82 2 2072 2731 yoonjh@snu.ac.kr | |
Sub-Investigator: Won Kim, M.D. |
Principal Investigator: | J H Yoon, Professor | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital ( Won Kim ) |
Study ID Numbers: | 07-2006-010 |
Study First Received: | July 26, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00357474 |
Health Authority: | Korea: Food and Drug Administration |
HCC, TACE, PEIT |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Mitomycins Doxorubicin Carcinoma Liver Neoplasms |
Digestive System Diseases Ethiodized Oil Mitomycin Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma Ethanol |
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 |