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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Transarterial chemoembolization

Percutaneous ethanol injection therapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, TACE, PEIT

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Seoul NUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

chemotherapy

ethanol

Arm Description

Transarterial chemoembolization (TACE)

Percutaneous ethanol injection therapy (PEIT)

Outcomes

Primary Outcome Measures

overall survival rate

Secondary Outcome Measures

Disease free survival rate and recurrence rate

Full Information

NCT ID

NCT00357474

First Posted

July 26, 2006

Last Updated

December 2, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00357474

Brief Title

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

Official Title

A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

To compare the below things between PEIT group and TACE group Survival 5 year overall survival rate Disease free survival rate Recurrence a. recurrence rate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

HCC, TACE, PEIT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

Transarterial chemoembolization (TACE)

Arm Title

ethanol

Arm Type

Active Comparator

Arm Description

Percutaneous ethanol injection therapy (PEIT)

Intervention Type

Procedure

Intervention Name(s)

Transarterial chemoembolization

Other Intervention Name(s)

TACE

Intervention Description

lipiodol, adriamycin and/or mitomycin

Intervention Type

Procedure

Intervention Name(s)

Percutaneous ethanol injection therapy

Other Intervention Name(s)

PEIT

Intervention Description

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

Primary Outcome Measure Information:

Title

overall survival rate

Time Frame

5 year

Secondary Outcome Measure Information:

Title

Disease free survival rate and recurrence rate

Time Frame

5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J H Yoon, Professor

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul NUH

City

Seoul

State/Province

Chongno-gu

ZIP/Postal Code

110-744

Country

Korea, Republic of

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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