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The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00397540
Collaborator
(none)
145
Enrollment
1
Location
2
Arms
78.9
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PEIT
  • Procedure: RFTA
 N/A

Detailed Description

Prospective cohort study

Survival

  • Overall survival rate

  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: percutaneous ethanol injection therapy

Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)

Procedure: PEIT
Percutaneous Ethanol Injection Therapy
Other Names:
  • PEI, local ablation therapy

    		•
    Active Comparator: radiofrequency thermal ablation

    Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)

    Procedure: RFTA
    Radiofrequency Thermal Ablation
    Other Names:
  • RFA, local ablation therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) [1,3,5 year]

      The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.

    Secondary Outcome Measures

    1. Overall Survival [through study completion, an average of 3 years]

      Overall Survival: Number of Participants who Died

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Child-Pugh Class A or B

    • Maximal tumor size less than 5 cm

    • No previous history of treatment for hepatocellular carcinoma

    • Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

    Exclusion Criteria:

    • Hepatocellular carcinoma in portal vein

    • Hepatocellular carcinoma in hepatic vein

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Director: Won Kim, Professor, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Hwan Yoon, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT00397540
    Other Study ID Numbers:
    • 10-2006-001
    First Posted:
    Nov 9, 2006
    Last Update Posted:
    Mar 18, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Jung-Hwan Yoon, Professor, Seoul National University Hospital
    HBV DNA
    HCC
    recurrence
    PEIT
    RFTA
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Carcinoma
    Carcinoma, Hepatocellular
    Hepatitis
    Recurrence

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
    Arm/Group Description 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
    Period Title: Overall Study
    STARTED 60 85
    COMPLETED 59 85
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title PEIT RFTA Total
    Arm/Group Description 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session. Total of all reporting groups
    Overall Participants 60 85 145
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    56
    58
    56
    Sex: Female, Male (Count of Participants)
    Female
    15
    25%
    11
    12.9%
    26
    17.9%
    Male
    45
    75%
    74
    87.1%
    119
    82.1%
    Region of Enrollment (participants) [Number]
    Korea, Republic of
    60
    100%
    85
    100%
    145
    100%
    Treatment modality (participants) [Number]
    Number [participants]
    60
    100%
    85
    100%
    145
    100%

    Outcome Measures

    1. Primary Outcome
    Title 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
    Description The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
    Time Frame 1,3,5 year

    Outcome Measure Data

    Analysis Population Description
    ITT analysis
    Arm/Group Title PEIT RFTA
    Arm/Group Description 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
    Measure Participants 62 84
    1 year-disease free survival
    11
    18.3%
    13
    15.3%
    3 year-disease free survival
    25
    41.7%
    34
    40%
    5 year-disease free survival
    26
    43.3%
    37
    43.5%
    2. Secondary Outcome
    Title Overall Survival
    Description Overall Survival: Number of Participants who Died
    Time Frame through study completion, an average of 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
    Arm/Group Description 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
    Measure Participants 60 85
    Number [participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
    Arm/Group Description 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
    All Cause Mortality
    Percutaneous Ethanol Injection Therapy RFTA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/85 (0%)
    Serious Adverse Events
    Percutaneous Ethanol Injection Therapy RFTA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/85 (0%)
    Other (Not Including Serious) Adverse Events
    Percutaneous Ethanol Injection Therapy RFTA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/85 (0%)

    Limitations/Caveats

    nothing to comment

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Won Kim
    Organization Seoul National University Hospital Boramae Medical Center
    Phone 82 2 870 2233
    Email wonshiri@yahoo.com
    Responsible Party:
    Jung-Hwan Yoon, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT00397540
    Other Study ID Numbers:
    • 10-2006-001
    First Posted:
    Nov 9, 2006
    Last Update Posted:
    Mar 18, 2019
    Last Verified:
    Mar 1, 2019