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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024846
Receipt No. 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

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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
Email 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
Email a-mori@anzu.or.jp

Sponsor
Institute Gastroenterology Ichinomiya Nishi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028593

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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