UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005437 |
|---|---|
| Receipt number | 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 13:00:28 |
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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
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
sasahira-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005969
