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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Radiofrequency ablation
Procedure: Microwave ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01340105
CT11005

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

93 participants in 2 patient groups

Microwave
Experimental group
Description:
Hepatocellular carcinoma treated with microwave ablation
Treatment:
Procedure: Microwave ablation
Radiofrequency
Active Comparator group
Description:
Hepatocellular carcinoma treated with radiofrequency ablation
Treatment:
Procedure: Radiofrequency ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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