UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of severity of post-ERCP pancreatitis by the drug pain score.
Title of the study (Brief title)	Post-ERCP pancreatitis and the drug pain score.
Region	Japan

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

Objectives
Narrative objectives1	Based on the criteria of the severity of PEP (post-ERCP pancreatitis) by the Ministry of Health, Labor and Welfare,and on the severity of PEP by DPS (Drug Pain score), (and by converting the analgesic use amount as DPS), evaluate the reliability the prediction of severity of PEP by DPS compare with the prediction of the severity of PEP by the criteria of the Ministry of Health, Labor and Welfare.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Converting analgesic use amount by DPS, establish PEP severity prediction model for reliability prediction of severity of PEP by DPS
Key secondary outcomes	1,DPS shows correlation with the severity criteria of the Ministry of Health, Labor and Welfare 2, DPS shows the severity earlier than the severity criteria of the Ministry of Health, Labor and Welfare 3. Calculate the cutoff value for prediction of PEP severity by DPS

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with consent capability with usual ERCP
Key exclusion criteria	1.minors 2.Patients who had EST. 3.Patients who are undergoing bile duct jejunostomy. 4.Pancreas / biliary stent placement. 5.Patients who had ERCP on non-hospitalization6.Patients with pancreatitis before ERCP (gallstone pancreatitis, obstructive pancreatitis, etc.).
Target sample size	10000

Research contact person
Name of lead principal investigator	Ryukichi akashi
Organization	Kumamoto City Medical Association Health Care Center
Division name	Endoscopy
Address	5-15-12 Honjo Chuo-ku Kumamotocity
TEL	096-366-2711
Email	a-kashi@krmc.or.jp

Public contact
Name of contact person	Ryukichi akashi
Organization	Kumamoto City Medical Association Health Care Center
Division name	Endoscopy
Address	5-15-12 Honjo Chuo-ku Kumamotocity
TEL	096-366-2711
Homepage URL
Email	a-kashi@krmc.or.jp

Sponsor
Institute	Kumamoto City Medical Association Health Care Center
Institute
Department

Funding Source
Organization	ZEON MEDICAL INC Boston scientific ]japan INC
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 09 Month 26 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 09 Month 26 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	nothing

Management information
Registered date	2017 Year 09 Month 25 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033468