Unique ID issued by UMIN | UMIN000016576 |
---|---|
Receipt number | R000019119 |
Scientific Title | Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease |
Date of disclosure of the study information | 2015/02/23 |
Last modified on | 2016/08/23 15:54:10 |
Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Renal arterial embolization with microspheres for polycystic kidney disease
Evaluation of effectiveness and safety of transcatheter renal arterial embolization with microspheres for polycystic kidney disease
Renal arterial embolization with microspheres for polycystic kidney disease
Japan |
Polycystic kidney disease
Nephrology | Urology | Radiology |
Others
NO
To evaluate the safety and effectiveness of transcatheter arterial embolization with microspheres for patients with symptomatic enlarged polycystic kidneys.
Safety,Efficacy
The volume reduction rate of the kidneys at three months after renal arterial embolization
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
12 months follow up
1 session embolization treatment
Complete occlusion of the targeted vessels with transcatheter microspheres injection
20 | years-old | <= |
Not applicable |
Male and Female
1) Age greater than 20 years
2) Enlargement of polycystic kidneys on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasonography (US), and suggestive symptoms related to polycystic kidneys such as markedly distended abdomen, gastroesophageal reflux, respiratory disorder, abdominal and/or low back pain, hematuria, and repetitive infectious cystitis
3) Already introduced to dialysis therapy for chronic renal failure
4) Urinary volume < 500 mL/day
5) Performance Status (ECOG) 0, 1, or 2
6) Provided enough written and oral information about this study, and given written informed consent to be registered in this study and undergo the procedure
1) Active inflammatory disease
2) Past history of malignant disease (except for carcinoma in situ) within five years before registration
3) Uncontrollded comorbid disease in the kidney, liver or heart.
4) Contraindication to iodized contrast material
5) Allergy to components (acrylic polymer and porcin gelatin) of microspheres (Embosphere)
6) Massive thoracic effusion
7) Massive ascites
8) Past history of renal arterial embolization
9) Hemoglobin < 8g/dL
10) Platelet count < 50,000 /mm3
11) Abnormalities in 12-led electrocardiogram (excluding clinically not significant abnormalities)
12) Pregnant or possibility being pregnant
13) Judged being not suitable by the principal or sub investigators
5
1st name | |
Middle name | |
Last name | Yusuke Sakuhara |
Hokkaido University Hospital
Diagnostic and Interventional Radiology
N-14, W-5, Kita-ku, Sapporo
011-716-1161(5977)
yusaku@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Yusuke Sakuhara |
Hokkaido University Hospital
Diagnostic and Interventional Radiology
N-14, W-5, Kita-ku, Sapporo
011-716-1161(5977)
yusaku@med.hokudai.ac.jp
Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital
Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Ministry of Health, Labor and Welfare
NO
2015 | Year | 02 | Month | 23 | Day |
Unpublished
No longer recruiting
2015 | Year | 02 | Month | 05 | Day |
2015 | Year | 02 | Month | 23 | Day |
2015 | Year | 02 | Month | 18 | Day |
2016 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019119