vascular malformation
Conditions
Interventions
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent is obtained by patient or parents. 2)Survival more than three months from a registration day can be expected. 3)Diagnosed as vascular malformation clinically(Characteristic image findings, US: hypoecho, MRI T2WI: high signal, phlebolith, skin color change, soft mass and so on) 4)Symptom (pain, swelling) thought to be due to vascular malformation is present. Or the lesion is progressive even if asymptomatic. 5) The lesion is apart from a vital organ or an important structure. 6) Operation is out of adaption or patient does not hope operation. 7) Medical treatment would not effect sufficiency. 8) Main organ function is kept. a. White blood-cell count >2,500/mm3 b. Platelet count >50,000/mm3 c. Hemoglobin >7.0g/mm3 d. Creatinin <2.0mg/dl e. Total bilirubin <3.0mg/dl
Exclusion criteria
Exclusion criteria: 1) Under 13 years old. 2) Patients have severe comorbidities as follows: a. Uncontroled malignant tumor. b. Serious lung disease. c. Serious heart trouble. d. Serious liver disease. e. Severe active inflammation and infectious disease. f. Poor control diabetes. g. Immunocompromised state including the whole steroid therapy. h. Case having complications considered to disturb completion of the cryoablation. 4) Past history of radiation exposure to the lesion. 5) Probe insertion can't be performed safely. 6) Clinical clear bleeding tendency (PT-INR >=1.5) 7) Drugs such as antiplatelet agent, anticoagulant, thrombolytic agent can't be ceased temporarily. 8) Being pregnant or may be pregnant. 9) Considered unsuitable for being enrolled in this clinical trial by a attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | — |
Countries
Japan
Contacts
Public ContactHiroyasu Fujiwara
Okayama University Hospital Department of Radiology
Outcome results
None listed