UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010210 |
|---|---|
| Receipt number | 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 14:14:30 |
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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
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
mi_taka_1112@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospotal
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011958
