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Evaluation of effectiveness and safety of transcatheter 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016576
Enrollment
5
Registered
2015-02-23
Start date
2015-02-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic kidney disease

Interventions

12 months follow up 1 session embolization treatment Complete occlusion of the targeted vessels with transcatheter microspheres injection

Sponsors

Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The volume reduction rate of the kidneys at three months after renal arterial embolization

Countries

Japan

Contacts

Public ContactYusuke Sakuhara

Hokkaido University Hospital Diagnostic and Interventional Radiology

yusaku@med.hokudai.ac.jp011-716-1161(5977)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026