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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043860
Receipt No. R000050058
Scientific Title Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study
Date of disclosure of the study information 2021/04/08
Last modified on 2021/04/07

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Basic information
Public title Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study
Acronym PEP Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP
Scientific Title Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study
Scientific Title:Acronym PEP Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP
Region
Japan

Condition
Condition Patients who undergo ERCP with trans-papilla.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the external validity of predictive scoring system for post ERCP pancreatitis immediately after ERCP, which was developed previously.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To verify the usefulness and external validity of this scoring system, we evaluate predictive diagnostic ability using Receiver Operating Characteristic analysis and the area under the curve.
Key secondary outcomes

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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. Consecutive patients with suspected hepatobiliary-pancreatic disorders who undergo trans-papillary ERCP attempts.
2. Patients who are obtained written informed consent to undergo ERCP.
Key exclusion criteria Patients or patients' family who reject the participation in this study, when the opportunity to opt out of this study participation was also provided.
Target sample size 3500

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Chiba
Organization The Jikei University School of Medicine, Tokyo, Japan
Division name Department of Endoscopy
Zip code 1058461
Address 3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL 334331113181
Email ccl09720@gmail.com

Public contact
Name of contact person
1st name Masafumi
Middle name
Last name Chiba
Organization The Jikei University School of Medicine, Tokyo, Japan
Division name Department of Endoscopy
Zip code 1058461
Address 3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL 334331113181
Homepage URL
Email ccl09720@gmail.com

Sponsor
Institute The Jikei University School of Medicine affiliated hospital.
The Jikei University Katsushika Medical Center.
The Jikei University Kashiwa Hospital.
Atsugi city hospital
Fuji city general hospital.
Institute
Department

Funding Source
Organization self-funding (The Jikei University School of Medicine)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Human Subjects Committee of Jikei University School of Medicine
Address 3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
Tel +81 3 34331111, ext. 2134
Email rinri@jikei.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 32-456 (10548)
Org. issuing International ID_1 Human Subjects Committee of Jikei University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属病院 東京慈恵会医科大学葛飾医療センター 東京慈恵会医科大学柏病院 厚木市立病院 富士市立中央病院

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 08 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 Open public recruiting
Date of protocol fixation
2021 Year 02 Month 04 Day
Date of IRB
2021 Year 03 Month 08 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter prospective cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who undergo trans-papillary ERCP attempts between April 1, 2021 and September 30, 2023.

Management information
Registered date
2021 Year 04 Month 07 Day
Last modified on
2021 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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