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Completed

NCT Number: NCT02539212

Comparison of Microwave and Radiofrequency Ablation for Liver

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.

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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

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

microwave ablation

Device

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

Radiofrequency Ablation

Device

ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Wilcoxon test was used for comparing liver function between MWA and RFA.

    Time frame: up to 79 months

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2015
Registry last updated
Sep 2, 2015

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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