UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the risk factors for severity in post-ERCP pancreatitis: about the indication of prophylactic treatment
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroshi Matsubara
Organization	Toyohashi Municipal Hospital
Division name	Department of Gastroenterology
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	Hiroshi Matsubara
Organization	Toyohashi Municipal Hospital
Division name	Department of Gastroenterology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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