UMIN-CTR Clinical Trial

Basic information
Public title	Dose the use of low osmolality contrast media reduce the frequency of post-ERCP pancreatitis? : a comparative study between use of low and high osmolality contrast media.
Acronym	Effect of low osmolality contrast media in post-ERCP pancreatitis
Scientific Title	Dose the use of low osmolality contrast media reduce the frequency of post-ERCP pancreatitis? : a comparative study between use of low and high osmolality contrast media.
Scientific Title:Acronym	Effect of low osmolality contrast media in post-ERCP pancreatitis
Region	Japan

Condition
Condition	Gastroenterology
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether low-osmotic contrast agent iodixanol suppresses post-ERCP pancreatitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PEP incidence rate by contrast agent
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	28 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent ERCP from October 2015 to December 2016.
Key exclusion criteria	Cases treated with nipple treatments such as endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD), cases with underlying malignancy, and cases with acute pancreatitis at the time of ERCP (cholecystolitic inflammation cases) , A case of reconstructed intestinal tract case, a self-expandable metal stent (SEMS) indwelling case, a case in which a pancreatic duct stent was indwelled after ERCP as PEP prevention
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Nagashima
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	tochigi,shimotugagunn,mibumachi,kitakobayashi-880
TEL	0282-86-1111
Email	n-kazu@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Nagashima
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	tochigi,shimotugagunn,mibumachi,kitakobayashi-880
TEL	0282-86-1111
Homepage URL
Email	n-kazu@dokkyomed.ac.jp

Sponsor
Institute	oota,memorial,hospital
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	dokkyo-Medical-University
Address	tochigi,shimotugagunn,mibumachi,kitakobayashi-880
Tel	0282-86-1111
Email	n-kazu@dokkyomed.ac.jp

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	2019 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	250
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2018 Year 02 Month 21 Day
Anticipated trial start date	2015 Year 10 Month 02 Day
Last follow-up date	2019 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	no

Management information
Registered date	2019 Year 06 Month 15 Day
Last modified on	2019 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042246