UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-
Title of the study (Brief title)	a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis
Region	Japan

Condition
Condition	Post-ERCP pancretitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate the effi cacy of rectally administered diclofenac plus sublingual nitrate compared with diclofenac alone to prevent post-ERCP panceatitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of post-ERCP pancreatitis
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	patients received a 5mg of sublingual nitrate before ERCP and received a suppository containing 50mg of diclofenac after ERCP.
Interventions/Control_2	patients received a suppository containing 50mg of diclofenac 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 planned ERCP
Key exclusion criteria	1)Patients with performance status 4. 2)Age<20 3)Body weight<50Kg 4)Patients who cannot access to Vater,s papilla. 5)Patients with a history of EST and EPBD. 6)Patients with acute pancreatitis 7)Patients with chronic pancreatitis 8)Patients with pancreatic head tumor 9)Patients who performed operation of reconstraction for intestinal track by gastrectomy. 10) Patients who had a contraindication to the use of NSAIDs and nitrate. 11) Patients who were already taking nitrates. 12)Patietns without informed concent. 13)Patients who are judged inappropriate by chief medical examiner.
Target sample size	900

Research contact person
Name of lead principal investigator	Hironari Kato
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterology & Hepatology
Address	2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	Takeshi Tomoda
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterology & Hepatology
Address	2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL	086-235-7219
Homepage URL
Email	tomotake79@yahoo.co.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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	2015 Year 02 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 03 Day
Anticipated trial start date	2015 Year 03 Month 18 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	2015 Year 01 Month 20 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018884