UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015420 |
|---|---|
| Receipt number | R000017933 |
| Scientific Title | EUS-HES for hilar biliary obstraction |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2021/04/17 09:12:25 |
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Basic information
Public title
EUS-HES for hilar biliary obstraction
Acronym
EUS-HES for hilar biliary obstraction
Scientific Title
EUS-HES for hilar biliary obstraction
Scientific Title:Acronym
EUS-HES for hilar biliary obstraction
Region
| Japan |
Condition
Condition
malignant hialr biliary obstraction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recovery from OJ, cholangitis, liver dysfunction
We evaluate within 14days after the porcedure.
Blood test, at tommorrow, 7days, 14days
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
interventional EUS
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.hilar biliary obstraction
2.high bilirubin level
3.liver dysfunction
4.cholangitis
Key exclusion criteria
1.pregnant
2.easy bleeding
3.short survival
4.massive hilar invasion
5.doctor disagree
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hara |
Organization
Aichi Cancer Center Hospital
Division name
gastroenterology
Zip code
Address
1-1 kanokoden tikusa-ku, Nagoya, Japan
TEL
052-762-6111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Hara |
Organization
Aichi Cancer Center Hospital
Division name
gastroenterology
Zip code
Address
1-1 kanokoden tikusa-ku, Nagoya, Japan
TEL
052-732-6111
Homepage URL
khara@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka medical university
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 21 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017933
