Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation

NCT ID: NCT01340105

Last Updated: 2022-03-21

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

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2018-03-31

Brief Summary

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The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).

The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.

A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.

Detailed Description

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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

NONE

Study Groups

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Microwave

Hepatocellular carcinoma treated with microwave ablation

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type PROCEDURE

Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Radiofrequency

Hepatocellular carcinoma treated with radiofrequency ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type PROCEDURE

Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Interventions

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Microwave ablation

Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Intervention Type PROCEDURE

Radiofrequency ablation

Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation
* Resectable HCC but patient opts for local ablation
* Maximum diameter of tumor ≤6cm
* Maximum number of tumor nodules ≤3
* Absence of radiology evidence of major vascular or bile duct invasion
* Child's A or B liver function
* Karnofsky performance status ≥70%

Exclusion Criteria

* Informed consent not available
* Pregnant female patients
* Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)
* HCC with history of rupture
* Concomitant hepatectomy
* Patients with chronic renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheung Yue Sun

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kit-fai Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, The Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CT11005

Identifier Type: -

Identifier Source: org_study_id

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