Hepatocellular carcinoma, metastatic liver cancer, cholangiocarcinoma
Conditions
Interventions
Irreversible Electroporation (IRE)
Sponsors
Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Older than 20 years, 2. Male or female, 3. Diagnosis of hepatocellular carcinoma, metastatic liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria, 4. Not suitable for surgical resection and patients who are not willing ot surgical resection, 5. Primary tumor is controlled, 6. The target nodule must have a diammeter of <= 10 cm, 7. Child-Pugh class A, 8. Platelet count > 50X10*9/L 9. Liver lesion visible on US, CT, or MRI, 10. ECOG score 0, 1, 11. ASA score <= 3, 12. Life expectancy of at least 12 weeks, 13, Written informed consent,
Exclusion criteria
Exclusion criteria: 1. Uncontrolled infection, 2. Heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker), 3. Pregnant women or women of childbearing potential not using an acceptable method of contraception, 4. Patient's disability to stop anticoagulant and antiplatelet therapy, 5. In the opinion of the researcher, anyone who cannot follow the calender of vist and asessment of the Protocol, 6. Patient received systemic chemotherapy within 4 weeks of treatment with the IRE NanoKnife,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of IRE for treatmetn of hepatic malignancies according to modified RECIST criteria using CT or MRI performed 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety within 30 days post-intervention. All adverse events will be classified according to CTCAE version 4.0 criteria. | — |
Countries
Japan
Contacts
Public ContactKatsutoshi Sugimoto
Tokyo Medical University Gastroenterology and Hepatology
Outcome results
None listed