UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere for Polycystic liever disease.
Title of the study (Brief title)	Safety of Embosifere for polycystic liver disease.
Region	Japan

Condition
Condition	Polycystic liver disease
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine a efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere in polycysitc liver disease patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety(Liver disfunction,liver failure, biliary infection)
Key secondary outcomes	improvement of QOL, reduction of liver volume, change of liver function, change of the number of platelet, The rate of a technological success

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 Embosphere
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) more than 20 years old 2) The patieng who are diacnosed by Computed Tomography, Magnetic resonance imaging or ultra sound and has a symptom such as abdominal distension, abdominal pain,behavioral disorder, respiration disorder, eating disorder,and back pain. 3) Child-Pugh score <6 4) A) Hemoglobin > 8 g/dL B) WBC >3000 /uL and <12000 /uL C) Platelet > 50000 /uL D) normal electocardiogram 5)Performance Status (ECOG)) is 0 to 2.
Key exclusion criteria	1) CRP> 1.0mg/dL 2) Total Bilirubin > 3mg/dL 3) Obstruction of portal vein 4) cancer patient 5) iodine hypersensitivity 6) A patient with a lot of ascites 7) A patient with a lot ofpleural effusion 8) Pregnant women 9) Not eligible for this study based on the decision's of a physician
Target sample size	5

Research contact person
Name of lead principal investigator	Saori Nishio
Organization	Hokkaido University Hospital
Division name	Internal medicine II
Address	15, Nishi 7, Kita-ku, Sapporo, Japan060-8638
TEL	011-706-5915
Email	saorin@med.hokudai.ac.jp

Public contact
Name of contact person	Takashi Miyakoshi
Organization	Hokkaido University Hospotal
Division name	Clinical Research and Medical Innovation Center Research and Development Division
Address	Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL	011-706-7923
Homepage URL
Email	mi_taka_1112@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospotal
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 11 Day
Anticipated trial start date	2013 Year 03 Month 12 Day
Last follow-up date	2016 Year 11 Month 02 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 12 Month 16 Day
Date analysis concluded

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

Management information
Registered date	2013 Year 03 Month 11 Day
Last modified on	2017 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011958