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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007691
Receipt No. R000009071
Scientific Title A feasibility and safetey of endoscopic ultrasound-guided transmural biliary drainage: A Japanese multicenter study.
Date of disclosure of the study information 2012/04/09
Last modified on 2014/03/27

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Basic information
Public title A feasibility and safetey of endoscopic ultrasound-guided transmural biliary drainage: A Japanese multicenter study.
Acronym A feasibility study of EUS-BD
Scientific Title A feasibility and safetey of endoscopic ultrasound-guided transmural biliary drainage: A Japanese multicenter study.
Scientific Title:Acronym A feasibility study of EUS-BD
Region
Japan

Condition
Condition Patients who underwent EUS-guided transmural biliary drainage
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and safety of EUS-guided transmural biliary drainage
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A rate of stent occlusion
Stent patency
A rate of stent dysfunction
Time to stent dysfunction
Key secondary outcomes Overall survival
A rate of complications

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 underwent EUS-guided transmural biliary drainage
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute The University of Tokyo
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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 A retrospective study

Management information
Registered date
2012 Year 04 Month 08 Day
Last modified on
2014 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009071

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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