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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010210
Receipt No. R000011958
Scientific Title A study of efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere for Polycystic liever disease.
Date of disclosure of the study information 2013/03/11
Last modified on 2017/05/29

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Basic information
Public title A study of efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere for Polycystic liever disease.
Acronym Safety of Embosifere for polycystic liver disease.
Scientific Title A study of efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere for Polycystic liever disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Saori Nishio
Organization Hokkaido University Hospital
Division name Internal medicine II
Zip code
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
1st name
Middle name
Last name Takashi Miyakoshi
Organization Hokkaido University Hospotal
Division name Clinical Research and Medical Innovation Center Research and Development Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 11 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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