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Comparison of Microwave and Radiofrequency Ablation for Liver

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

microwave ablation

radiofrequency ablation

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring microwave, radiofrequency, ablation

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

microwave ablation

radiofrequency ablation

Arm Description

microwave ablation

radiofrequency ablation

Outcomes

Primary Outcome Measures

Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

Secondary Outcome Measures

disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.

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

Full Information

NCT ID

NCT02539212

First Posted

August 12, 2015

Last Updated

August 31, 2015

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02539212

Brief Title

Comparison of Microwave and Radiofrequency Ablation for Liver

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

microwave, radiofrequency, ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

microwave ablation

Arm Type

Active Comparator

Arm Description

microwave ablation

Arm Title

radiofrequency ablation

Arm Type

Active Comparator

Arm Description

radiofrequency ablation

Intervention Type

Device

Intervention Name(s)

microwave ablation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

radiofrequency ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Time Frame

up to 79 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping Liang, Doctor

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

12. IPD Sharing Statement

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Comparison of Microwave and Radiofrequency Ablation for Liver

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