UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005676 |
|---|---|
| Receipt number | 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 16:34:36 |
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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
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
mochiduki-ypch@umin.ac.jp
Sponsor or person
Institute
Yamanashi Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006712
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
