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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029279
Receipt No. 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

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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
Email 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
Email a-kashi@krmc.or.jp

Sponsor
Institute Kumamoto City Medical Association Health Care Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033468

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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