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Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

NCT ID: NCT00357474

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

Detailed Description

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To compare the below things between PEIT group and TACE group

1. Survival

1. 5 year overall survival rate
2. Disease free survival rate
2. Recurrence a. recurrence rate

Conditions

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Hepatocellular Carcinoma

Keywords

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HCC, TACE, PEIT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chemotherapy

Transarterial chemoembolization (TACE)

Group Type ACTIVE_COMPARATOR

Transarterial chemoembolization

Intervention Type PROCEDURE

lipiodol, adriamycin and/or mitomycin

ethanol

Percutaneous ethanol injection therapy (PEIT)

Group Type ACTIVE_COMPARATOR

Percutaneous ethanol injection therapy

Intervention Type PROCEDURE

99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week

Interventions

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Transarterial chemoembolization

lipiodol, adriamycin and/or mitomycin

Intervention Type PROCEDURE

Percutaneous ethanol injection therapy

99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week

Intervention Type PROCEDURE

Other Intervention Names

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TACE PEIT

Eligibility Criteria

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Inclusion Criteria

* The evidences of HBV(+) \&/or HCV(+) infection or liver cirrhosis
* Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
* The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
* 1\) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
* It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion Criteria

* In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Hwan Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J H Yoon, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul NUH

Seoul, Chongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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07-2006-010

Identifier Type: -

Identifier Source: org_study_id