Comparison of Microwave and Radiofrequency Ablation for Liver

August 31, 2015 updated by: Ping Liang, Chinese PLA General Hospital

A Randomized Controlled Trial of Microwave and Radiofrequency Ablation in the Treatment of Early-stage Hepatocellular Carcinoma Meeting Milan Criteria

According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to following enrollment standard, about >400 cases of biopsy-proved hepatocellular carcinoma(HCC) patients will be involved in the study. They will be treated with percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is selected for the patient according to the sequence of their visit to the hospital based on randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic effectiveness will be compared between two modalities.

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • tumor size ≤5cm in diameter,
  • tumor number ≤3,
  • Child-Pugh class A or B classification,
  • no evidence of extrahepatic metastasis,
  • vein or bile duct tumor embolus, and
  • no any other anti-cancer treatment

Exclusion Criteria:

  • not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: microwave ablation
Device: microwave ablation
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
ACTIVE_COMPARATOR: radiofrequency ablation
Device: radiofrequency ablation
ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
Time Frame: up to 79 months
up to 79 months

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
Time Frame: up to 79 months
up to 79 months
Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
Time Frame: up to 79 months
up to 79 months
An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.
Time Frame: up to 79 months
up to 79 months
Wilcoxon test was used for comparing liver function between MWA and RFA.
Time Frame: up to 79 months
up to 79 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (ESTIMATE)

September 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 939530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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