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

NCT ID: NCT00844454

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QFEA

multi-pronged ethanol ablation

Group Type EXPERIMENTAL

multi-pronged ethanol ablation

Intervention Type PROCEDURE

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.

RFA

radiofrequency ablation

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.

Interventions

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multi-pronged ethanol ablation

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.

Intervention Type PROCEDURE

radiofrequency ablation

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming-de Lu

Department of Medical Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingde Lu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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EARFArct2007

Identifier Type: -

Identifier Source: secondary_id

EARFArct

Identifier Type: -

Identifier Source: org_study_id

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