Comparison of Microwave and Radiofrequency Ablation for Liver

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539212
• Other study ID #: 939530
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: August 31, 2015
• Start date: October 2008
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• microwave ablation
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
• radiofrequency ablation
ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.		up to 79 months
Secondary	Wilcoxon test was used for comparing liver function between MWA and RFA.		up to 79 months