UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002642 |
|---|---|
| Receipt number | R000003209 |
| Scientific Title | Assessment of new criteria for post-ERCP pancreatitis. |
| Date of disclosure of the study information | 2009/10/19 |
| Last modified on | 2014/05/07 13:07:10 |
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Basic information
Public title
Assessment of new criteria for post-ERCP pancreatitis.
Acronym
Assessment of new criteria for post-ERCP pancreatitis.
Scientific Title
Assessment of new criteria for post-ERCP pancreatitis.
Scientific Title:Acronym
Assessment of new criteria for post-ERCP pancreatitis.
Region
| Japan |
Condition
Condition
post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of new criteria for post-ERCP pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of new criteria for post-ERCP pancreatitis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 undergo ERCP
Key exclusion criteria
Biliary pancreatitis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tooru Shimosegawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7171
suizo@gastroente.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Masamune |
Organization
Tohoku University School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
Homepage URL
suizo@gastroente.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this prospective study is to assess the usefulness of the new diagnositic criteria for post-ERCP pancreatitis.
Management information
Registered date
| 2009 | Year | 10 | Month | 19 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003209
