UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029279 |
|---|---|
| Receipt number | R000033468 |
| Scientific Title | Assessment of severity of post-ERCP pancreatitis by the drug pain score. |
| Date of disclosure of the study information | 2017/09/26 |
| Last modified on | 2018/10/11 15:30:56 |
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Basic information
Public title
Assessment of severity of post-ERCP pancreatitis by the drug pain score.
Acronym
Post-ERCP pancreatitis and the drug pain score.
Scientific Title
Assessment of severity of post-ERCP pancreatitis by the drug pain score.
Scientific Title:Acronym
Post-ERCP pancreatitis and the drug pain score.
Region
| Japan |
Condition
Condition
Post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the criteria of the severity of PEP (post-ERCP pancreatitis) by the Ministry of Health, Labor and Welfare,and on the severity of PEP by DPS (Drug Pain score), (and by converting the analgesic use amount as DPS), evaluate the reliability the prediction of severity of PEP by DPS compare with the prediction of the severity of PEP by the criteria of the Ministry of Health, Labor and Welfare.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Converting analgesic use amount by DPS, establish PEP severity prediction model for reliability prediction of severity of PEP by DPS
Key secondary outcomes
1,DPS shows correlation with the severity criteria of the Ministry of Health, Labor and Welfare
2, DPS shows the severity earlier than the severity criteria of the Ministry of Health, Labor and Welfare
3. Calculate the cutoff value for prediction of PEP severity by DPS
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 with consent capability with usual ERCP
Key exclusion criteria
1.minors
2.Patients who had EST.
3.Patients who are undergoing bile duct jejunostomy.
4.Pancreas / biliary stent placement.
5.Patients who had ERCP on non-hospitalization6.Patients with pancreatitis before ERCP (gallstone pancreatitis, obstructive pancreatitis, etc.).
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryukichi akashi |
Organization
Kumamoto City Medical Association Health Care Center
Division name
Endoscopy
Zip code
Address
5-15-12 Honjo Chuo-ku Kumamotocity
TEL
096-366-2711
a-kashi@krmc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryukichi akashi |
Organization
Kumamoto City Medical Association Health Care Center
Division name
Endoscopy
Zip code
Address
5-15-12 Honjo Chuo-ku Kumamotocity
TEL
096-366-2711
Homepage URL
a-kashi@krmc.or.jp
Sponsor or person
Institute
Kumamoto City Medical Association Health Care Center
Institute
Department
Personal name
Funding Source
Organization
ZEON MEDICAL INC
Boston scientific ]japan INC
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033468
