UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011978 |
|---|---|
| Receipt number | R000013990 |
| Scientific Title | Wire-guided cannulation: J shaped-tip or straight-tip guidewire |
| Date of disclosure of the study information | 2013/10/08 |
| Last modified on | 2018/10/11 11:57:59 |
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Basic information
Public title
Wire-guided cannulation: J shaped-tip or straight-tip guidewire
Acronym
WGC: J-shaped or straight tip guidewire
Scientific Title
Wire-guided cannulation: J shaped-tip or straight-tip guidewire
Scientific Title:Acronym
WGC: J-shaped or straight tip guidewire
Region
| Japan |
Condition
Condition
Biliary disorders
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy of J-shaped tip guidewire for selective biliary cannulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful biliary cannulation
Key secondary outcomes
Adverse event
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
Biliary cannulation attempt with J-shaped tip GW for 10 min. If failed, biliary cannulation attempt with straight tip GW for another 10 min.
Interventions/Control_2
Biliary cannulation attempt with straight tip GW for 10 min. If failed, biliary cannulation attempt with J-shaped tip GW for another 10 min.
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)Naive papilla
(2)Requirement for biliary cannulation
(3)Written informed consent
Key exclusion criteria
(1)Impossible endoscopic intubation
(2)Performance status 4
(3)After papilloplasty
(4)Surgically-altered anatomy
(5)Severe comorbidities in other organ
(6)No receipt of informed consent
(7)Patients considered unsuitable for enrollment
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iruru Maetani |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
maetani-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iruru Maetani |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology an
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
Homepage URL
maetani-gi@umin.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 08 | 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
| 2013 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 14 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013990
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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