Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liever disease.
- Conditions
- Polycystic liver disease or Autosomal dominant polycystic kidney disease
- Registration Number
- JPRN-UMIN000017705
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
1) Patients with Active inflammatory disease (CRP over 2.0 mg/dl) 2) Patients with leukocyte count which exceeds institutional standards' upper limit 3) Patients with blood platelet count less than 50,000 /micro l 4) Patients with serum bilirubin concentration more than 3 mg/dl 5) Patients with AST/ALT which is higher than five times of the institutional standards' upper limit 6) Patient with glomerulus filtration (eGFR) less than 30 ml/min/1.73m 2. 7) Patients with fully closed portal vein. 8) Patients who has diagnosed with malignant tumor within 5 years from provisional registration 9) Patients with Renal Disease, Liver Disease and/or Heart Disease with unfavorable prognosis 10) Patients with history of iodine contrast agent hypersensitivity 11) Patients who have shown hyper sensitivity to ingredients of NK939 (acrylic polymers, gelatin) 12) Pleural effusion which requires invasive treatments 13) Ascites which requires invasive treatments 14) Patients with past history of transcatheter arterial embolization 15) Patients with past history of hepatectomy / puncture within 3 years from registration 16) Patients with concurrence of liver cyst and cyst kidney has occurred and adequate for kidney TAE (after dialysis introduction (blood, peritoneal) and self-volume of urine less than 500 ml/day). If the symptom remains after kidney TAE, the patients may be enrolled. 17) Patients who started Tolvaptan within 6 months from acquisition of written consent 18) Pregnant/lactating women. Fertile Women who are unable to practice contraception 19) Patients whom principal investigator or sub investigator have determined inadequate for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method