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NCT Number: NCT01340105

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microwave ablation

Procedure

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

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. Complete ablation rate

    Time frame: 1 month

    Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)

Secondary outcomes

  1. Treatment related mortality

    Time frame: 30-day

    Mortality within 30 days after operation

  2. Recurrent disease

    Time frame: 3 year

    It is defined as the imaging detected new lesions

  3. Survival

    Time frame: 3 year

    Overall and disease-free survival

  4. Long-term liver function

    Time frame: 3 year

    Monitoring of liver function test result and the occurrance of decompensated cirrhosis

  5. Treatment related morbidity

    Time frame: 30-day

    Complications related to the treatment received

  6. Hospital stay

    Time frame: 30-day

    Total length of hospital stay (days)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Apr 22, 2011
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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