hepatocellular carcinoma
Conditions
Interventions
radiofrequency ablation
new-generation microwave ablation
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient at the age of 20 to 100 when the informed consent was obtained 2. Patient with histopathologically confirmed carcinoma or tumors showing characteristic imaging features of hepatocellular carcinoma 3. Tumors were unresectable or patient declined surgery 4. Three or fewer tumors, each 3 cm or less in diameter, or a solitary lesion, 5 cm or less in diameter (Patients with both primary and recurrent tumors were included. Patients with local tumor progression were excluded) 5. No extrahepatic metastasis or vascular invasion 6. Patient with written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactSHUICHIRO SHIINA
Juntendo University Department of Gastroenterology
Outcome results
None listed