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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Microwave ablation; Procedure: Radiofrequency ablation

• Registration Number: NCT01340105
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2017-03
• Study Completion: 2018-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-05
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave	Microwave ablation	Hepatocellular carcinoma treated with microwave ablation
Radiofrequency	Radiofrequency ablation	Hepatocellular carcinoma treated with radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Complete ablation rate	1 month	Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)

Secondary Outcome Measures

Name	Time	Method
Treatment related mortality	30-day	Mortality within 30 days after operation
Long-term liver function	3 year	Monitoring of liver function test result and the occurrance of decompensated cirrhosis
Recurrent disease	3 year	It is defined as the imaging detected new lesions
Survival	3 year	Overall and disease-free survival
Treatment related morbidity	30-day	Complications related to the treatment received
Hospital stay	30-day	Total length of hospital stay (days)

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China