UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024814 |
|---|---|
| Receipt number | R000028558 |
| Scientific Title | A multicenter, prospective, observational study for the association serum pancreatic enzyme level and CT image findings in post-ERCP pancreatitis |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2016/11/12 20:16:51 |
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Basic information
Public title
A multicenter, prospective, observational study for the association serum pancreatic enzyme level and CT image findings in post-ERCP pancreatitis
Acronym
A multicenter, prospective, observational study for CT image findings in post-ERCP pancreatitis
Scientific Title
A multicenter, prospective, observational study for the association serum pancreatic enzyme level and CT image findings in post-ERCP pancreatitis
Scientific Title:Acronym
A multicenter, prospective, observational study for CT image findings in post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
Post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation serum pancreatic enzyme level and CT image findings in post-ERCP pancreatitis.
Basic objectives2
Others
Basic objectives -Others
correlative analysis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Determination of cutoff value of serum pancreatic enzyme level in post-ERCP pancreatitis
Key secondary outcomes
Determination of cutoff value of serum pancreatic enzyme level in severe post-ERCP pancreatitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with elevated serum pancreatic enzyme level in all cases that underwent ERCP
Key exclusion criteria
Patients disagree with this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyohito Tanaka |
Organization
Kyoto Second Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
Address
355-5 Haruobicho Kamannza Marutamachi Kamigyo ward Kyoto city
TEL
075-231-5171
seijin7705@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Inatomi |
Organization
Shiga University of Medical Science
Division name
Department of Gastroenterology
Zip code
Address
Seta-Tsukinowa cho, Otsu city, Shiga
TEL
077-548-2217
Homepage URL
osam@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kyoto Second Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
京都第二日赤病院（京都府）
京都第一赤十字病院（京都府）
京都医療センター（京都府）
桂病院（京都府）
滋賀医科大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective, observational study
Subjects; consecutive patients who underwent ERCP in 5 institutions (5000 cases for 2years)
Endpoints: Patients characteristics, years experience of the operators, procedure time, procedure protocol, procedural complication rate, serum pancreatic enzymes level
Analysis: Determination of cutoff value using ROC analysis for serum pancreatic enzyme level and pancreatitis diagnosed by CT image findings
Management information
Registered date
| 2016 | Year | 11 | Month | 12 | Day |
Last modified on
| 2016 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028558
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
