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A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hepatic resection
Radiofrequency ablation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

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

Inclusion Criteria:

  1. Age between 20 and 70 years
  2. Child-Pugh class A (score 5-6)
  3. Single hepatocellular carcinoma
  4. Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
  5. No previous treatment
  6. Platelet count > 80,000/mm3

Exclusion Criteria:

  1. HCC abutting main hepatic veins or the first branches of the main portal vein
  2. HCC abutting vessels ≥ 0.5 cm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Hepatic resection

    Radiofrequency ablation

    Arm Description

    Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.

    Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.

    Outcomes

    Primary Outcome Measures

    The patient survival

    Secondary Outcome Measures

    The disease-free survival

    Full Information

    First Posted
    June 20, 2015
    Last Updated
    June 25, 2015
    Sponsor
    Seoul National University Hospital
    Collaborators
    National Cancer Center, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02482909
    Brief Title
    A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma
    Official Title
    A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    The post-treatment recurrence rate was expected to be different between two treatment groups.
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    National Cancer Center, Korea

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Hepatic resection
    Arm Type
    Experimental
    Arm Description
    Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.
    Arm Title
    Radiofrequency ablation
    Arm Type
    Experimental
    Arm Description
    Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hepatic resection
    Intervention Description
    Anatomical surgical resection of the liver including the tumor
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiofrequency ablation
    Intervention Description
    Percutaneous ablation using radiofrequency under the imaging guidance
    Primary Outcome Measure Information:
    Title
    The patient survival
    Time Frame
    From the intervention up to 5 years or until the death of the participant whichever came first
    Secondary Outcome Measure Information:
    Title
    The disease-free survival
    Time Frame
    From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first

    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: Age between 20 and 70 years Child-Pugh class A (score 5-6) Single hepatocellular carcinoma Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT) No previous treatment Platelet count > 80,000/mm3 Exclusion Criteria: HCC abutting main hepatic veins or the first branches of the main portal vein HCC abutting vessels ≥ 0.5 cm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyung-Suk Suh, ME, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

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