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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Operation
Percutaneous ethanol injection therapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, operation, percutaneous ethanol injection

Eligibility Criteria

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

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)

Sites / Locations

  • Seoul NUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgery

local therapy

Arm Description

Outcomes

Primary Outcome Measures

overall survival rate

Secondary Outcome Measures

disease free survival rate and recurrence rate

Full Information

First Posted
July 26, 2006
Last Updated
September 6, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00357422
Brief Title
Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)
Official Title
Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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 solitary, small hepatocellular carcinoma.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, operation, percutaneous ethanol injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Active Comparator
Arm Title
local therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Operation
Other Intervention Name(s)
surgery
Intervention Description
No drug needed
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 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)
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

12. IPD Sharing Statement

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

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