UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024846 |
|---|---|
| Receipt number | R000028593 |
| Scientific Title | ERCP using a micro guidewire in cases of difficult biliary cannulation: a prospective feasibility study |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2019/05/20 08:01:20 |
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Basic information
Public title
ERCP using a micro guidewire in cases of difficult biliary cannulation: a prospective feasibility study
Acronym
ERCP using a micro guidewire in cases of difficult biliary cannulation
Scientific Title
ERCP using a micro guidewire in cases of difficult biliary cannulation: a prospective feasibility study
Scientific Title:Acronym
ERCP using a micro guidewire in cases of difficult biliary cannulation
Region
| Japan |
Condition
Condition
Obstructive Jaundice
Choledocholithiasis
Biliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of ERCP using microguidewire in cases of difficult biliary cannulaation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase of technical success rate
Key secondary outcomes
Increase of safety in ERCP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Selective biliary cannulation using microguidewire
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of difficult biliary cannulation in conventional ERCP
Key exclusion criteria
Cases with difficulty in endoscopic approach to duodenal pappila
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Mori |
Organization
Ichinomiya Nishi Hospital
Division name
Gastr
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
| 2016 | Year | 11 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028593
