UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013196 |
|---|---|
| Receipt number | R000015388 |
| Scientific Title | Comparison of a straight and angled tip guide wire in wire-guided biliary cannulation technique |
| Date of disclosure of the study information | 2014/02/19 |
| Last modified on | 2014/02/18 23:20:34 |
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Basic information
Public title
Comparison of a straight and angled tip guide wire in wire-guided biliary cannulation technique
Acronym
Comparison of a straight and angled tip guide wire in wire-guided biliary cannulation technique
Scientific Title
Comparison of a straight and angled tip guide wire in wire-guided biliary cannulation technique
Scientific Title:Acronym
Comparison of a straight and angled tip guide wire in wire-guided biliary cannulation technique
Region
| Japan |
Condition
Condition
Biliary diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparsion of biliary cannulation rate between using straight and angled tip guidewire
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of 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
| Maneuver |
Interventions/Control_1
Biliary cannulation using straight tip guidewire
Interventions/Control_2
Biliary cannulation using angle tip guidewire
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. Diagnostic or therapeutic ERCP for biliary disease and naiive papilla
2. Patients who understand and are willing to give a written informed consent about participation
Key exclusion criteria
1.Patients with performance status Grade 4
2.Patients with tumor of amppulla of the Vater.
3.patients with surgically-altered anatomy of upper gastro intestinal tract excluding Billroth I method.
4.Patients considered ineligible for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi IRISAWA |
Organization
Fukushima Medical University Aizu Medical Center
Division name
gastroenterology
Zip code
Address
21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL
(0242)75-2100
irisawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koh IMBE |
Organization
Fukushima Medical University Aizu Medical Center
Division name
gastroenterology
Zip code
Address
21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL
(0242)75-2100
Homepage URL
kohimbe@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University Aizu Medical Center
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
| 2014 | Year | 02 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
Management information
Registered date
| 2014 | Year | 02 | Month | 18 | Day |
Last modified on
| 2014 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015388
