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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009291
Receipt No. R000010734
Scientific Title A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Date of disclosure of the study information 2012/11/09
Last modified on 2013/12/10

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Basic information
Public title A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Acronym A prospective randomized controlled trial of WGC using J and straight tip guidewire.
Scientific Title A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Scientific Title:Acronym A prospective randomized controlled trial of WGC using J and straight tip guidewire.
Region
Japan

Condition
Condition Biliary and pancreatic diseases requiring biliary tract catheter insertion.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the successful insertion rate between J and straight tip guidewire for WGC.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Successful insertion rate
Key secondary outcomes Complication rate
Time of deep cannulation
Cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Biliary cannulation in WGC using J tip guidewire
Interventions/Control_2 Biliary cannulation in WGC using straight tip guidewire
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)Patients require biluary tract catheter insertion, with no history of duodenal papilla treatment.
(2)Patients who understand and are willing to give a written informed consent about participation.
Key exclusion criteria (1)Patients with gastrectomy by Billroth II and Roux-en-Y renstruction
(2)Patients in Perfomance status 4
(3)Patients require ERP
(4)Patients with severe complication inother organs
(5)Patients judged by principal investigator to be inadequate as subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Watanabe Seitaro
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku Yokohama, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku Yokohama, Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute Yokohama City University Hospital, Gastroenterology Division
Institute
Department

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
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 11 Month 09 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
2012 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 22 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
2012 Year 11 Month 08 Day
Last modified on
2013 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010734

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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