UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015752 |
|---|---|
| Receipt number | R000018332 |
| Scientific Title | Randomized controlled trial to compare the onset rate of the acute pancreatitis with hyperosmotic contrast media with the equal penetration in ERCP |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2016/11/28 06:20:49 |
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Basic information
Public title
Randomized controlled trial to compare the onset rate of the acute pancreatitis with hyperosmotic contrast media with the equal penetration in ERCP
Acronym
Randomized controlled trial of the onset rate of the pancreatitis after ERCP by the difference in contrast media
Scientific Title
Randomized controlled trial to compare the onset rate of the acute pancreatitis with hyperosmotic contrast media with the equal penetration in ERCP
Scientific Title:Acronym
Randomized controlled trial of the onset rate of the pancreatitis after ERCP by the difference in contrast media
Region
| Japan |
Condition
Condition
The case that ERCP needs
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the pancreatitis onset rate by the difference in contrast media
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of acute pancreatitis
Key secondary outcomes
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Contrast medium
Interventions/Control_2
Age
Interventions/Control_3
gender
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
The case that ERCP needs
Key exclusion criteria
Past history of post-ERCP acute pancreatitis
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Ogura |
Organization
Osaka Medical Colledge
Division name
Gastroenterology
Zip code
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ogura |
Organization
Osaka Medical Colledge
Division name
Gastroenterology
Zip code
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Colledge
Institute
Department
Personal name
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
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
| 2014 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 11 | Month | 25 | Day |
Last modified on
| 2016 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018332
