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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022086
Receipt No. R000025466
Scientific Title Analysis of the risk factors for severity in post-ERCP pancreatitis: about the indication of prophylactic treatment
Date of disclosure of the study information 2016/04/26
Last modified on 2016/04/26

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Basic information
Public title Analysis of the risk factors for severity in post-ERCP pancreatitis: about the indication of prophylactic treatment
Acronym Analysis of the risk factors for severity in post-ERCP pancreatitis
Scientific Title Analysis of the risk factors for severity in post-ERCP pancreatitis: about the indication of prophylactic treatment
Scientific Title:Acronym Analysis of the risk factors for severity 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 determine the risk factors of severe post-ERCP pancreatitis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the risk factors of severe 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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients of post-ERCP pancreatitis
Key exclusion criteria Patients accompanied by acute pancreatitis at the time of undergoing ERCP
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsubara
Organization Toyohashi Municipal Hospital
Division name Department of Gastroenterology
Zip code
Address 50 Hakkennishi, Aotake-cho, Toyohashi 441-8570, Japan
TEL 0532-33-6111
Email matsubara-hiroshi@toyohashi-mh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsubara
Organization Toyohashi Municipal Hospital
Division name Department of Gastroenterology
Zip code
Address 50 Hakkennishi, Aotake-cho, Toyohashi 441-8570, Japan
TEL 0532-33-6111
Homepage URL
Email matsubara-hiroshi@toyohashi-mh.jp

Sponsor
Institute Toyohashi Municipal Hospital
Institute
Department

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
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
2016 Year 04 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 Completed
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 Retrospective observational study

Management information
Registered date
2016 Year 04 Month 26 Day
Last modified on
2016 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025466

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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