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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005437
Receipt No. R000005969
Scientific Title Can Early Double Guidewire Technique Facilitate Common Bile Duct Cannulation and Reduce Risk of Post ERCP Pancreatitis? Multicenter randomized controlled trial
Date of disclosure of the study information 2011/04/14
Last modified on 2014/04/21

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Basic information
Public title Can Early Double Guidewire Technique Facilitate Common Bile Duct Cannulation and Reduce Risk of Post ERCP Pancreatitis? Multicenter randomized controlled trial
Acronym EDUCATION study
Scientific Title Can Early Double Guidewire Technique Facilitate Common Bile Duct Cannulation and Reduce Risk of Post ERCP Pancreatitis? Multicenter randomized controlled trial
Scientific Title:Acronym EDUCATION study
Region
Japan

Condition
Condition Biliary disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Early Double Guidewire Technique Facilitate Common Bile Duct Cannulation and Reduce Risk of Post ERCP Pancreatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of successful biliary cannulation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Double guidewire method
Interventions/Control_2 Repeated wtandard wire guided cannulation method
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 Naiive papilla,
Diagnostic or therapeutic ERCP for biliary disease
In case with unintended insertion of guidewire into pancreatic duct
Key exclusion criteria State after B-II, Roux-en-Y
Pancreatobiliary maljunction,
Pancreas divisum
Acute pancreatitis
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Sasahira
Organization The University of Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-Ku
TEL 03-3815-5411
Email sasahira-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Sasahira
Organization The University of Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email sasahira-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization No
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
2011 Year 04 Month 14 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
2011 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 14 Day
Last modified on
2014 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005969

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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