UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial
Title of the study (Brief title)	High and low trial
Region	Japan

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

Objectives
Narrative objectives1	Non inferiority of Low dose VS high dose rectal diclofenac for prevention of post ERCP pancreatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Non inferiority of Low dose VS high dose rectal diclofenac for prevention of post ERCP pancreatitis
Key secondary outcomes	severity of pancreatitis adverse event serum AMY level 2 hours and one day after ERCP Spread of inflamation in serum AMY high level

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	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Rectal administration of 0.5mg/kg diclofenac within 30 min. after ERCP
Interventions/Control_2	Rectal administration of 1.0mg/kg diclofenac within 30 min. after ERCP
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are scheduled to undergo ERCP and who undergo emergency ERCP from 8:00 to 17:30
Key exclusion criteria	emergency ERCP from 17:30 to 8:30 eGFR<50 choledocholithiasis with pancreatitis aspirin induced asthma pregnancy Triamterene oral administration <20age shock vital NSAIDs allergy
Target sample size	900

Research contact person
Name of lead principal investigator	Kusumoto Kiyonori
Organization	Kyoto Katsura Hospital
Division name	Department of gastroenterology
Address	Yamadahirao17,nisikyouku,Kyoto city,Japan
TEL	075-391-5811
Email	kusumoto1024@gmail.com

Public contact
Name of contact person	Kusumoto Kiyonori
Organization	Kyoto Katsura Hospital
Division name	Department of gastroenterology
Address	Yamadahirao17,nisikyouku,Kyoto city,Japan
TEL	075-391-5811
Homepage URL
Email	kusumoto1024@gmail.com

Sponsor
Institute	Kyoto Katsura Hospital
Institute
Department

Funding Source
Organization	Kyoto Katsura Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tango central hospital
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 01 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 25 Day
Anticipated trial start date	2016 Year 01 Month 05 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	2016 Year 01 Month 06 Day
Last modified on	2017 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023621