UMIN-CTR Clinical Trial

Basic information
Public title	The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: A Propensity Score Analysis
Acronym	Prediction model for PEP
Scientific Title	The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: 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	https://link.springer.com/article/10.1007/s00464-020-08173-4
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00464-020-08173-4
Number of participants that the trial has enrolled	3362
Results	Chiba, M., Kato, M., Kinoshita, Y. et al. The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: a propensity score analysis. Surg Endosc (2020). https://doi.org/10.1007/s00464-020-08173-4
Results date posted	2020 Year 12 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 30 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 12 Month 01 Day

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