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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040471
Receipt No. R000046196
Scientific Title Establishment and Validation of a Simplified Predictive Scoring System for Post-ERCP Pancreatitis: A Propensity Score Analysis
Date of disclosure of the study information 2020/05/22
Last modified on 2020/05/22

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Basic information
Public title Establishment and Validation of a Simplified Predictive Scoring System for Post-ERCP Pancreatitis: A Propensity Score Analysis
Acronym Prediction model for PEP
Scientific Title Establishment and Validation of a Simplified Predictive Scoring System for Post-ERCP Pancreatitis: A Propensity Score Analysis
Scientific Title:Acronym Prediction model for PEP
Region
Japan

Condition
Condition Consecutive trans-papillary ERCP procedures were retrospectively analyzed.
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to establish a simplified predictive scoring system for PEP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After a predictive scoring system for PEP was established, the usability of the present model was evaluated. The results were also internally validated using bootstrapping resampling.
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 The present study was a retrospective single-center cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent trans-papillary ERCP attempts between January 1, 2012 and December 31, 2019.
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 3362

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 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
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
Division name Department of Endoscopy
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email ccl09720@gmail.com

Sponsor
Institute The Jikei University School of Medicine
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 32-027 (10102)
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病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 22 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 3362
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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
2020 Year 05 Month 18 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2020 Year 05 Month 20 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information The present study was a retrospective single-center cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent trans-papillary ERCP attempts between January 1, 2012 and December 31, 2019.

Management information
Registered date
2020 Year 05 Month 21 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046196

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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