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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015420
Receipt No. R000017933
Scientific Title EUS-HES for hilar biliary obstraction
Date of disclosure of the study information 2015/08/21
Last modified on 2015/08/30

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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
Email 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
Email khara@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

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
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

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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
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
2015 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017933

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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