Comparison Study of Operation and PEIT for Small, Solitar... | NCT00357422

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

NCT00357422

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 10, 2018Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

Operation
Percutaneous ethanol injection therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 26, 2006

First Submission Date that Met QC Criteria

Jul 26, 2006

First Posted Date

Jul 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2018

Last Update Posted Date

Sep 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-Hwan Yoon, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Survival
- 5 year overall survival rate
- Disease free survival rate
Recurrence
- Cumulative recurrence rate

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery	Active Comparator		Procedure: Operation
local therapy	Active Comparator		Procedure: Percutaneous ethanol injection therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Operation	Procedure	No drug needed	surgery	surgery

Measure	Description	Time Frame
overall survival rate		5 year

Measure	Description	Time Frame
disease free survival rate and recurrence rate		5 year

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J H Yoon, Professor	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul NUH		Seoul	Chongno-gu	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided