UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liever disease.
Title of the study (Brief title)	Efficacy of Embosifere for polycystic liver disease.
Region	Japan

Condition
Condition	Polycystic liver disease or Autosomal dominant polycystic kidney disease
Classification by specialty	Nephrology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of transcatheter arterial embolization with Embosphere® in polycysitc liver disease patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1 The volume reduction rate of the liver at six months after TAE 2 Change of abdominal fullness at six months after TAE
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	TAE with NK939
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	25

Research contact person
Name of lead principal investigator	Saori Nishio
Organization	Hokkaido University Hospital
Division name	Internal medicine II
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan060-8638
TEL	011-706-5916
Email	saorin@med.hokudai.ac.jp

Public contact
Name of contact person	Takashi Miyakoshi
Organization	Hokkaido University Hospital
Division name	Clinical Research and Medical Innovation Center
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Japan060-8638
TEL	011-706-7923
Homepage URL
Email	mi_taka_1112@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	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
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 19 Day
Anticipated trial start date	2015 Year 02 Month 09 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 20 Day
Date trial data considered complete	2017 Year 11 Month 21 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020511