A multicenter randomized controlled trial of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma

Not Applicable

Recruiting

• Conditions: hepatocellular carcinoma

• Registration Number: JPRN-UMIN000035442
• Lead Sponsor: Juntendo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient with prothrombin activity of 50% or less. Patient with low platelet count that cannot be corrected by lusutrombopag or platelet transfusion 2. Patient with refractory ascites and at high risk of peritoneal bleeding 3. Patient with enterobiliary reflux 4. Contrast-enhanced CT cannot be performed because of renal dysfunction (creatinine of 2 mg/dL or more) or allergic adverse reactions to iodine contrast agents 5. Child-Pugh class C 6. ASA's (American Society of Anesthesiologists) physical score 3 or above 7. Patient who cannot accept necessary treatments, such as blood transfusion, because of religious reasons and others 8. Patient who cannot follow medical instructions because of dementia and others 9. Patient with tumors not visualized by ultrasonography or not accessible 10. Patient with adhesion between tumors and the gastrointestinal tract which may cause GI tract penetration or perforation 11.Patient with tumors adjacent to the major Glisson's capsule which may cause serious biliary injury or hepatic infarction 12.Patient not considered eligible to participate in this study by the attending doctor due to various reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the technical success rate evaluated by the CT scan taken after the first session of new-generation microwave ablation or radiofrequency ablation The secondary endpoints are 1) complete ablation ratio of tumors after the final session of of new-generation microwave ablation or radiofrequency ablation, 2) the number of sessions until completion of the treatment, and adverse event ratio.