Comparison of Microwave and Radiofrequency Ablation for Liver
A Randomized Controlled Trial of Microwave and Radiofrequency Ablation in the Treatment of Early-stage Hepatocellular Carcinoma Meeting Milan Criteria
1 other identifier
interventional
403
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Oct 2008
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedSeptember 2, 2015
August 1, 2015
6.7 years
August 12, 2015
August 31, 2015
Conditions
Keywords
Outcome Measures
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.
up to 79 months
Secondary Outcomes (4)
disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
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.
up to 79 months
An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.
up to 79 months
Wilcoxon test was used for comparing liver function between MWA and RFA.
up to 79 months
Study Arms (2)
microwave ablation
ACTIVE COMPARATORmicrowave ablation
radiofrequency ablation
ACTIVE COMPARATORradiofrequency ablation
Interventions
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ping Liang, Doctor
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair
Study Record Dates
First Submitted
August 12, 2015
First Posted
September 2, 2015
Study Start
October 1, 2008
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08