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

September 6, 2018 updated by: Jung-Hwan Yoon, Seoul National University Hospital

Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

  1. Survival

    • 5 year overall survival rate
    • Disease free survival rate

  2. Recurrence

    • Cumulative recurrence rate

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: surgery
Procedure: Operation
No drug needed
Other Names:
  • surgery
Active Comparator: local therapy
Procedure: Percutaneous ethanol injection therapy
99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week
Other Names:
  • PEIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival rate
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival rate and recurrence rate
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: J H Yoon, Professor, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-2007-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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