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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005676
Receipt No. R000006712
Scientific Title Comparison of 8mm with 10mm Balloon Dilater for Endoscopic Papillary Dilatation Therapy of Common Bile Duct Stones.
Date of disclosure of the study information 2011/06/01
Last modified on 2018/12/05

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Basic information
Public title Comparison of 8mm with 10mm Balloon Dilater for Endoscopic Papillary Dilatation Therapy of Common Bile Duct Stones.
Acronym Comparison of 8mm with 10mm Bapillary Balloon Dilator.
Scientific Title Comparison of 8mm with 10mm Balloon Dilater for Endoscopic Papillary Dilatation Therapy of Common Bile Duct Stones.
Scientific Title:Acronym Comparison of 8mm with 10mm Bapillary Balloon Dilator.
Region
Japan

Condition
Condition Common Bile Duct Stones
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the usefuliness of 8mm vs.10mm of endoscopic papillary balloon dilator
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Removal of Common Bile Duct Stones
Key secondary outcomes Occurrence of adverse reaction
Recurrence of Common Bile Duct Stones

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Balloon dilator of 8mm diameter.
Interventions/Control_2 Balloon dilator of 8mm diameter.
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 have common bile duct stone/stones
Key exclusion criteria Patient who express disagreement.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi MOCHIZUKI
Organization Yamanashi Central Hospital
Division name Division of Gastroenterology
Zip code
Address 1-1-1 Fujimi,Kofu,Yamanashi,Japan
TEL 055-263-7111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi MOCHIZUKI
Organization Yamanashi Central Hospital
Division name Division of Gastroenterology
Zip code
Address 1-1-1Fujimi,Kofu,Yamanashi,Japan
TEL 055-263-7111
Homepage URL http://www.ych.pref.yamanashi.jp/bumon/yakuzai/chiken.html
Email mochiduki-ypch@umin.ac.jp

Sponsor
Institute Yamanashi Central Hospital
Institute
Department

Funding Source
Organization Yamanashi Central Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 山梨県立中央病院(山梨県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 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
2011 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2017 Year 06 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 30 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006712

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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