UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010082 |
|---|---|
| Receipt number | R000011809 |
| Scientific Title | A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewires |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2014/08/20 13:02:35 |
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Basic information
Public title
A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewires
Acronym
A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewires
Scientific Title
A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewires
Scientific Title:Acronym
A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewires
Region
| Japan |
Condition
Condition
Biliary and pancreatic disease required endoscopic bile duct cannulation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We estimate the difference in the cannulation success rate and complication of selective bile duct cannulation by different guidewires.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of selective bile duct cannulation and incidence of complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are 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
From April, 2011 to March, 2013
Interventions/Control_2
From April, 2011 to March, 2013
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient required endoscopic bile duct cannulation
Key exclusion criteria
The patient under 15 years old, without communication and agreement
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Kitamura |
Organization
Showa University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8535
k.kitamura@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Kitamura |
Organization
Showa University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8535
Homepage URL
k.kitamura@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
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
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
昭和大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 20 | 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 | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2013 | Year | 02 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011809
