UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prevntional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Title of the study (Brief title)	The preventional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography.
Region	Japan

Condition
Condition	acute pancreatitis after endoscopic retrograde cholangiopancreatography
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will invesigate the preventional effect of celecoxib on acute pancreatitis after endoscopic retrograde cholangiopancreatography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1:incidence rate of acute pancreatitis 2:serum amylase level
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	celecoxib fo oral administration
Interventions/Control_2	no treatment
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	all patients who are examined endoscopic retrograde cholangiopancreatography
Key exclusion criteria	digestive organ ulcer
Target sample size	50

Research contact person
Name of lead principal investigator	Adachi Tomohiko
Organization	Nagasaki University
Division name	department of surgery
Address	1-7-1 Sakamoto Nagasaki
TEL	095-819-7316
Email	adatomo-ngs@umin.net

Public contact
Name of contact person	Tomohiko Adachi
Organization	University of Nagasaki
Division name	department surgery
Address	1-7-1, Sakamoto, Nagasaki
TEL	095-819-7316
Homepage URL
Email	adatomo@nifty.com

Sponsor
Institute	Depatment of surgery University of Nagasaki
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

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
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	2012 Year 03 Month 07 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008805