UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029279
Receipt number R000033468
Scientific Title Assessment of severity of post-ERCP pancreatitis by the drug pain score.
Date of disclosure of the study information 2017/09/26
Last modified on 2018/10/11 15:30:56

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Basic information

Public title

Assessment of severity of post-ERCP pancreatitis by the drug pain score.

Acronym

Post-ERCP pancreatitis and the drug pain score.

Scientific Title

Assessment of severity of post-ERCP pancreatitis by the drug pain score.

Scientific Title:Acronym

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

1st name
Middle name
Last name Ryukichi akashi

Organization

Kumamoto City Medical Association Health Care Center

Division name

Endoscopy

Zip code


Address

5-15-12 Honjo Chuo-ku Kumamotocity

TEL

096-366-2711

Email

a-kashi@krmc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryukichi akashi

Organization

Kumamoto City Medical Association Health Care Center

Division name

Endoscopy

Zip code


Address

5-15-12 Honjo Chuo-ku Kumamotocity

TEL

096-366-2711

Homepage URL


Email

a-kashi@krmc.or.jp


Sponsor or person

Institute

Kumamoto City Medical Association Health Care Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name