A Study Comparing Radiofrequency Ablation and Hepatic Res... | NCT02482909

Studies
A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

NCT02482909

Sponsor

Seoul National University Hospital

Status

Terminated

Last Update Posted

Jun 26, 2015Estimated

Enrollment

68Actual

Phase

Not Applicable

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatic resection
Radiofrequency ablation

Countries

Not provided

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The post-treatment recurrence rate was expected to be different between two treatment groups.

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

May 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 20, 2015

First Submission Date that Met QC Criteria

Jun 25, 2015

First Posted Date

Jun 26, 2015Estimated

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

Jun 25, 2015

Last Update Posted Date

Jun 26, 2015Estimated

Name	Class
National Cancer Center, Korea	OTHER_GOV

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 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.

Detailed Description

Not provided

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

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatic resection	Experimental	Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.	Procedure: Hepatic resection
Radiofrequency ablation	Experimental	Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.	Procedure: Radiofrequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatic resection	Procedure	Anatomical surgical resection of the liver including the tumor	Hepatic resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The patient survival		From the intervention up to 5 years or until the death of the participant whichever came first

Secondary Outcomes

Measure	Description	Time Frame
The disease-free survival		From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first

Other Outcomes

Not provided

Eligibility Module

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

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

Name	Affiliation	Role
Kyung-Suk Suh, ME, PhD	Seoul National University Hospital	Study Director

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
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided