UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, prospective, observational study for the incidence and high risk factor of post-ERCP pancreatitis
Title of the study (Brief title)	A multicenter, prospective, observational study for 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 clarify the incidence and high risk factors of post-ERCP pancreatitis by the multicenter prospective study
Basic objectives2	Others
Basic objectives -Others	epidemiologic analysis
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of post-ERCP pancreatitis
Key secondary outcomes	Risk factors for post-ERCP pancreatitis Risk factors and predictive factors for 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	All patients who underwent ERCP during the observational period
Key exclusion criteria	Patients disagree with this study
Target sample size	5000

Research contact person
Name of lead principal investigator	Kiyohito Tanaka
Organization	Kyoto Second Red Cross Hospital
Division name	Department of Gastroenterology
Address	355-5 Haruobicho Kamannza Marutamachi Kamigyo ward Kyoto city
TEL	075-231-5171
Email	seijin7705@gmail.com

Public contact
Name of contact person	Osamu Inatomi
Organization	Shiga University of Medical Science
Division name	Department of Gastroenterology
Address	Seta-Tsukinowa cho, Otsu city
TEL	077-548-2217
Homepage URL
Email	osam@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Gastroenterology, Kyoto Second Red Cross 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)

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	京都第二赤十字病院（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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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, 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028555