The safety and efficacy of microwave ablation and radiofrequency ablation for colorectal cancer liver metastasis : A randomized controlled clinical trial

Not Applicable

Recruiting

• Conditions: Colorectal liver metastasis

• Registration Number: JPRN-UMIN000036206
• Lead Sponsor: Juntendo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Study Completion: 2020-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patient with platelet of 50,000/mm3 or less. Patient with PT of 50% or less. 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. ASA's (American Society of Anesthesiologists) physical score 3 or above 6. Patient who cannot accept necessary treatments, such as blood transfusion, because of religious reasons and others 7. Patient who cannot follow medical instructions because of dementia and others 8. Patient with tumors not visualized by ultrasonography or not accessible 9. Patient with adhesion between tumors and the gastrointestinal tract which may cause GI tract penetration or perforation 10.Patient with tumors adjacent to the major Glisson's capsule which may cause serious biliary injury or hepatic infarction 11.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 Modified RECIST evaluated by the CT scan taken after the first session of microwave ablation or radiofrequency ablation.

Secondary Outcome Measures

Name	Time	Method
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.