Hepatocellular carcinoma, metastatic hepatocellular carcinoma
Conditions
Interventions
Using the Histotripsy system, a high-pressure (15-25 MPa) ultrasound pulse (<10msec) is focused percutaneously to a single point (3-6 mm in diameter) in the body, and the generated bubbles are accumul
Sponsors
Ishizawa Takeaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria 1) Patients who are diagnosed with typical hepatocellular carcinoma (High absorption in the early phase and low absorption in the late phase) or metastatic liver cancer on abdominal dynamic CT or MRI and have a treatment-target lesion with a maximum diameter of 3 cm or less 2) The treatment-target lesion is not associated with obvious extrahepatic lesions, vascular invasion, or tumor thrombus on imaging 3) The entire treatment-target lesion can be visualized without any defect on abdominal ultrasonography 4) Is not associated with obvious portal vein thrombosis on imaging 5) Liver function is Child-Pugh score 7 points or less 6) Major organ (Bone marrow, liver, kidney) function is sufficiently preserved 7) Age >= 20 years and < 90 years at the date of obtaining consent 8) Written informed consent for participation in the study was obtained from the patient
Exclusion criteria
Exclusion criteria: 1) Prominent symptoms of portal hypertension (Platelet count <5x10^4/microL or untreated gastroesophageal varices) 2) Active double cancer (Do not include lesions corresponding to carcinoma in situ or carcinoma in situ) 3) Myocardial infarction or unstable angina diagnosed within 6 months before enrollment 4) Interstitial pneumonia, pulmonary fibrosis, or emphysema deemed difficult to administer the study 5) Patients who cannot undergo contrast-enhanced CT or MRI for reasons such as allergy or decreased renal function 6) Comorbidity of psychiatric disorders that make it difficult to conduct this clinical study 7) Patients who are pregnant or may be pregnant 8) Other patients deemed inappropriate for enrollment by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-Term efficacy (liquefaction of the target lesion on contrast-enhanced CT the day after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Short-term safety (presence or absence of adverse events) -Feasibility (Cost of treatment and appropriateness of treatment schedule) | — |
Contacts
Public ContactTakeaki Ishizawa
Osaka Metropolitan University Hospital
Outcome results
None listed