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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009415
Receipt No. R000005570
Scientific Title A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD
Date of disclosure of the study information 2012/11/27
Last modified on 2019/07/31

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Basic information
Public title A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD
Acronym A randomized-controlled trial of 4Fr.ENPBD
Scientific Title A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD
Scientific Title:Acronym A randomized-controlled trial of 4Fr.ENPBD
Region
Japan

Condition
Condition Disease for which biliary or pancreatic duct drainage is necessary
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the safety of 4Fr.ENPBD to that of 6Fr.ENBD and 5Fr.ENPD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of acute pancreatitis and hyperpancreaticamylasemia post placement of ENPBD
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 4Fr.ENPBD
Interventions/Control_2 5Fr.ENPD and 6Fr.ENBD
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 who are expected to use ENPBD tube
Key exclusion criteria Patients who have history of EST or EPBD.
Patients who are expected to be undergone EST or EPBD.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sasaki Tamito
Organization Hiroshima university hospital
Division name Department of Gastroenterology and metabolism
Zip code
Address Kasumi 1-2-3, minami-ku, hiroshima-shi
TEL 082-257-5591
Email suiken@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishigaki Takashi
Organization Hiroshima University
Division name Department of Medicine and Molecular Science
Zip code
Address Kasumi 1-2-3, minami-ku, hiroshima-shi
TEL 082-257-5591
Homepage URL
Email suiken@hiroshima-u.ac.jp

Sponsor
Institute Department of Gastroenterology and metabolism of Hiroshima university hospital
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 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 12 Month 22 Day
Date of IRB
2011 Year 01 Month 06 Day
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 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
2012 Year 11 Month 27 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005570

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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