NCT00357422

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable hepatocellular-carcinoma

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, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

5.8 years

First QC Date

July 26, 2006

Last Update Submit

September 6, 2018

Conditions

Hepatocellular Carcinoma

Keywords

HCC, operation, percutaneous ethanol injection

Outcome Measures

Primary Outcomes (1)

  • overall survival rate

    5 year

Secondary Outcomes (1)

  • disease free survival rate and recurrence rate

    5 year

Study Arms (2)

surgery

ACTIVE COMPARATOR
Procedure: Operation

local therapy

ACTIVE COMPARATOR
Procedure: Percutaneous ethanol injection therapy

Interventions

OperationPROCEDURE

No drug needed

Also known as: surgery
surgery
Percutaneous ethanol injection therapyPROCEDURE

99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week

Also known as: PEIT
local therapy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • In case of hepatic vein or portal vein invasion radiologically (CT or MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul NUH

Seoul, Chongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • J H Yoon, Professor

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

KR(1)