UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033069
Receipt No. R000037707
Scientific Title Multi center research of Follow-up study of QOL evolution after clinical trial of Transcatheter Arterial Embolization with Embosphere for Polycystic liver disease.
Date of disclosure of the study information 2018/06/20
Last modified on 2019/06/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multi center research of Follow-up study of QOL evolution after clinical trial of Transcatheter Arterial Embolization with Embosphere for Polycystic liver disease.
Acronym Follow-up study of QOL evolution after clinical trial of TAE with Embosphere for Polycystic liver disease.
Scientific Title Multi center research of Follow-up study of QOL evolution after clinical trial of Transcatheter Arterial Embolization with Embosphere for Polycystic liver disease.
Scientific Title:Acronym Follow-up study of QOL evolution after clinical trial of TAE with Embosphere for Polycystic liver disease.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy of Transcatheter Arterial Embolization (TAE) treatment with QOL evolution etc. at 36 months after transcatheter arterial embolization with Embosphere; in polycysitc liver disease patients who participated in [Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liver disease] or [A study of efficacy and safety of Transcatheter Arterial Embolization(TAE) with Embosphere for Polycystic liver disease]
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes QOL evolution and Change in QOL evolution after TAE
Key secondary outcomes -Liver volume and the volume reduction rate of the liver
-Liver cyst volume and the volume reduction rate of the liver cyst
-Treatment rerated Adverse events

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patients who participated in [Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liver disease] or[A study of efficacy and safety of Transcatheter Arterial Embolization (TAE) with Embosphere for Polycystic liver disease]
-Patients from whom written informed consent to participate in this trial has been obtained after sufficient explanation receiving and having understanding
Key exclusion criteria -Not eligible for this study based on the decision 's of a physician
Target sample size 35

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 Kita 15, Nishi 7, Kita-ku, Sapporo, Japan 060-8638
TEL 011-706-5916
Email saorin@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Miyakoshi
Organization Hokkaido University Hospital
Division name Clinical Research and Medical Innovation Center
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Japan 060-8638
TEL 011-706-7923
Homepage URL
Email mi_taka_1112@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor -Tokyo Women's Medical University Hospital
-Niigata University Medical & Dental Hospital
-Osaka University Hospital
-Juntendo Unversity Hospital
-Teikyo University Hospital
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(北海道)、東京女子医科大学病院(東京都) 、新潟大学医歯学総合病院(新潟県)、大阪大学医学部附属病院(大阪府) 、順天堂大学医学部附属順天堂医院(東京都)、帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 16 Day
Date of IRB
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 18 Day
Last follow-up date
2019 Year 06 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

To evaluate efficacy of Transcatheter Arterial Embolization (TAE) treatment with QOL evolution etc. at 36 months after transcatheter arterial embolization with Embosphere

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037707

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.