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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008180
Receipt No. R000009638
Scientific Title Multi-Center, Prospective Study of 0.025 inch guidewire for ERCP related procedure
Date of disclosure of the study information 2012/06/16
Last modified on 2012/06/15

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Basic information
Public title Multi-Center, Prospective Study of 0.025 inch guidewire for ERCP related procedure
Acronym VIP study
Scientific Title Multi-Center, Prospective Study of 0.025 inch guidewire for ERCP related procedure
Scientific Title:Acronym VIP study
Region
Japan

Condition
Condition Pancreatobiliary disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical utility of 0.025 inch guidewire for ERCP related procedure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate
Key secondary outcomes Complication rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pancreatobiliary disease.
20 yeare old<=
Patients who gives written informed consent.
Key exclusion criteria Patients considered ineligible for this study.
Patients without written informed consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio TSUYUGUCHI
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji SAKAI
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Homepage URL
Email

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Chiba University 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
Address
Tel
Email

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
2012 Year 06 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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2012 Year 06 Month 15 Day
Last modified on
2012 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009638

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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