UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized trial of pancreatic stent placement and NSAIDs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis
Title of the study (Brief title)	A randomized trial of pancreatic stent placement and NSAIDs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis
Region	Japan

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

Objectives
Narrative objectives1	NSAIDs for prevention of post-endoscopic retrograde cholangiopancreatogrephy pancreatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The occurrence of post ERCP pancreatitis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are 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	50mmg of rectal non-steroidal anti-inflamation drugs,30 min before ERCP
Interventions/Control_2	Pancreatic duct stent
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 scheduled to undergo ERCP are included.
Key exclusion criteria	acute pancreatitis,chronic pancreatitis with acute painful exacerbation,peptic ulcer,rectal disease,aspirin-induced asthma,NSAIDs during the preceding 1 week,hypersensitivity to NSAIDs,severe renal dysfunction,pregnant,breast-feeding,inability to provide written informed consent
Target sample size	300

Research contact person
Name of lead principal investigator	Takao Kato
Organization	Hyogo prefectural Awaji Medical Center
Division name	Department of Gatroenteterology
Address	1-1-17 sumoto,Hyogo,Japan
TEL	0799-22-1200
Email	takao.k@juno.ocn.ne.jp

Public contact
Name of contact person	Takao Kato
Organization	Hyogo prefectural Awaji Medical Center
Division name	Department of Gatroenteterology
Address	1-1-17 sumoto,Hyogo,Japan
TEL	0799-22-1200
Homepage URL
Email	takao.k@juno.ocn.ne.jp

Sponsor
Institute	Hyogo prefectural Awaji Medical Center
Institute
Department

Funding Source
Organization	Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2018 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 04 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	2018 Year 03 Month 13 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036208