NCT00397540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

6.6 years

First QC Date

November 7, 2006

Results QC Date

September 22, 2009

Last Update Submit

March 14, 2019

Conditions

Carcinoma, HepatocellularChronic Hepatitis B

Keywords

HBV DNAHCCrecurrencePEITRFTA

Outcome Measures

Primary Outcomes (1)

  • 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)

    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.

    1,3,5 year

Secondary Outcomes (1)

  • Overall Survival

    through study completion, an average of 3 years

Study Arms (2)

percutaneous ethanol injection therapy

ACTIVE COMPARATOR

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

Procedure: PEIT

radiofrequency thermal ablation

ACTIVE COMPARATOR

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

Procedure: RFTA

Interventions

PEITPROCEDURE

Percutaneous Ethanol Injection Therapy

Also known as: PEI, local ablation therapy
percutaneous ethanol injection therapy
RFTAPROCEDURE

Radiofrequency Thermal Ablation

Also known as: RFA, local ablation therapy
radiofrequency thermal ablation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hepatocellular carcinoma in portal vein
  • Hepatocellular carcinoma in hepatic vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5.

    PMID: 23461618DERIVED

  • Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x.

    PMID: 22011297DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis B, ChronicRecurrence

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Limitations and Caveats

nothing to comment

Results Point of Contact

Title
Won Kim
Organization
Seoul National University Hospital Boramae Medical Center
wonshiri@yahoo.com
82 2 870 2233

Study Officials

  • Won Kim, Professor

    Seoul National University Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

October 1, 2004

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 18, 2019

Results First Posted

March 15, 2010

Record last verified: 2019-03

Locations

KR(1)