UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025546 |
|---|---|
| Receipt number | R000029401 |
| Scientific Title | Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial- |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2023/01/10 12:45:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial-
Acronym
Application of a micro guidewire to selective biliary cannulation in ERCP
Scientific Title
Application of a micro guidewire to selective biliary cannulation in ERCP -Prospective randomized pilot trial-
Scientific Title:Acronym
Application of a micro guidewire to selective biliary cannulation in ERCP
Region
| Japan |
Condition
Condition
Obstructive jaundice
choledocholithiasis
biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether a micro guidewire facilitate selective biliary cannulation in ERCP compared to a conventional guidewire
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of time and increase of success rate for selective biliary cannulation in ERCP
Key secondary outcomes
safety,feasibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: 0.016 micro guidewire
Only use in ERCP
Interventions/Control_2
Control: 0.025 guidewire
Only use in ERCP
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Biliary diseases
Key exclusion criteria
Patients with a history of endoscopic sphincterotomy and with papilla tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Mori |
Organization
Ichinomiya Nishi Hospital
Division name
Gastroenterology
Zip code
4940001
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
a-mori@anzu.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Mori |
Organization
Ichinomiya Nishi Hospital
Division name
Gastroenterology
Zip code
4940001
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
Homepage URL
a-mori@anzu.or.jp
Sponsor or person
Institute
Gastroenterology Ichinomiya Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology Ichinomiya Nishi Hospital
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
Ichinomiya Nishi Hospital
Address
1 Hira Kaimei Ichinomiya Aichi
Tel
0586480077
a-mori@anzu.or.jp
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
| 2017 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
No data
Results date posted
| 2023 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No data
Participant flow
random
Adverse events
None
Outcome measures
No data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029401
