Polycystic liver disease or Autosomal dominant polycystic kidney disease
Conditions
Interventions
TAE with NK939
Sponsors
Hokkaido University Hospital
Tokyo Women'
s Medical University Hospital Hospital attached to the Teikyo University medical department Niigata University Medical &
Dental Hospital Osaka University Hospital Juntendo Unversity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients between the ages of 20 to 80 years at the time of obtaining written consent 2) Patients who have been diagnosed with type 2 or type 3 polycystic liver by Gigot category with CT, MRI or Ultra Sound 3) Patients who scored more than 3 points of NRS twice between acquisition of written consent and registration. 4) Patients who scores 0, 1 or 2 for PS(ECOG Performance Status) 5) Patients to whom sufficient information have been provided and with his/her full understanding of the trial, written consent have been obtained
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 The volume reduction rate of the liver at six months after TAE 2 Change of abdominal fullness at six months after TAE | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 The volume reduction rate of the liver cysts at six months after TAE 2 Change in QOL score 3 Success rate of target vessel embolization 4 Improvement of nutritional status (serum albumin, hematocrit) 5 Improvement of portal hypertension (platelet) 6 Improvement of respiratory function 7 Reduction rate of maximum circumferential abdominal girth | — |
Countries
Japan
Contacts
Public ContactTakashi Miyakoshi
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Outcome results
None listed