UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to compare the onset rate of the acute pancreatitis with hyperosmotic contrast media with the equal penetration in ERCP
Title of the study (Brief title)	Randomized controlled trial of the onset rate of the pancreatitis after ERCP by the difference in contrast media
Region	Japan

Condition
Condition	The case that ERCP needs
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare the pancreatitis onset rate by the difference in contrast media
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of acute pancreatitis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Contrast medium
Interventions/Control_2	Age
Interventions/Control_3	gender
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	The case that ERCP needs
Key exclusion criteria	Past history of post-ERCP acute pancreatitis
Target sample size	600

Research contact person
Name of lead principal investigator	Takeshi Ogura
Organization	Osaka Medical Colledge
Division name	Gastroenterology
Address	2-7 Daigakuchou, Takatsukishi, Osaka
TEL	072-683-1221
Email	oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person	Takeshi Ogura
Organization	Osaka Medical Colledge
Division name	Gastroenterology
Address	2-7 Daigakuchou, Takatsukishi, Osaka
TEL	072-683-1221
Homepage URL
Email	oguratakeshi0411@yahoo.co.jp

Sponsor
Institute	Osaka Medical Colledge
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 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

Management information
Registered date	2014 Year 11 Month 25 Day
Last modified on	2016 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018332