Multi-pronged Ethanol Ablation and Radiofrequency Ablatio... | NCT00844454

Studies
Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma

NCT00844454

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Oct 8, 2019Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

multi-pronged ethanol ablation
radiofrequency ablation

Countries

China

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

ID	Type	Description	Link
EARFArct2007

Status Module

Record Verification Date

Oct 2019

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

May 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Feb 13, 2009

First Submission Date that Met QC Criteria

Feb 13, 2009

First Posted Date

Feb 16, 2009Estimated

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

Oct 5, 2019

Last Update Posted Date

Oct 8, 2019Actual

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 compare the effectiveness of percutaneous ethanol ablation using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA) in the treatment of early-stage hepatocellular carcinoma (HCC).

Detailed Description

Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol ablation. The local treatment responses, complications,and long-term disease-free survivals and overall survivals are analyzed.

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

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QFEA	Experimental	multi-pronged ethanol ablation	Procedure: multi-pronged ethanol ablation
RFA	Active Comparator	radiofrequency ablation	Procedure: radiofrequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multi-pronged ethanol ablation	Procedure	Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.

Measure	Description	Time Frame
Local treatment responses		2 years

Measure	Description	Time Frame
Disease-free survivals and overall survivals		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm
Ultrasound detectable tumor
Liver function classified as Child-Pugh A or B
Platelet count > 50,000/mm3, or prothrombin activity > 50%
Not suitable for resection or patient refused surgery

Exclusion Criteria:

Vascular invasion and extrahepatic spread
Patients allergic to ethanol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Mingde Lu, Prof.	Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Sun Yat-Sen University		Guangzhou	Guangdong	510080	China

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