UMIN-CTR Clinical Trial

Basic information
Public title	Prediction rule for post-ERCP pancreatitis
Acronym	Prediction rule for post-ERCP pancreatitis
Scientific Title	Prediction rule for post-ERCP pancreatitis
Scientific Title:Acronym	Prediction rule for post-ERCP pancreatitis
Region	Japan

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

Objectives
Narrative objectives1	The Aim of this study is to develop a practical prediction rule for post-ERCP pancreatitis.
Basic objectives2	Others
Basic objectives -Others	prediction rule
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	post-ERCP pancreatitis
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criterion was patients who underwent transpapillary ERCP.
Key exclusion criteria	Exclusion criteria were under 18 years old, patients with clinical evidence of acute pancreatitis at the time of the procedure, and patients with altered gastrointestinal anatomy. e.g. Roux-en-Y reconstruction.
Target sample size	2500

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Fujita
Organization	Yodogawa Christian Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	533-0024
Address	1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
TEL	06-6322-2250
Email	koichifujitarm@gmail.com

Public contact
Name of contact person	1st name Koichi Middle name Last name Fujita
Organization	Yodogawa Christian Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	533-0024
Address	1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
TEL	06-6322-2250
Homepage URL
Email	koichifujitarm@gmail.com

Sponsor
Institute	Yodogawa Christian Hospital
Institute
Department

Funding Source
Organization	none
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	Institutional Review Board, Yodogawa Christian Hospital
Address	1-7-50, Kunijima, Higashiyodogawa-ku, Osaka, Japan
Tel	06-6322-2250
Email	rinri@ych.or.jp

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	淀川キリスト教病院(大阪） 公益法人田附興風会医学研究所北野病院（大阪） 京都大学医学部付属病院（京都）

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 14 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/full/10.1002/jgh3.12634
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/full/10.1002/jgh3.12634
Number of participants that the trial has enrolled	2719
Results	PEP developed in 133 cases (4.9%). A scoring system was constructed using these seven clinical variables. The areas under the receiver-operating characteristic curve of this model were 0.799 in the training set and 0.791 in the validation set. In the high-risk group at a score of 3 or higher, the incidence of PEP was 13.4%, and all severe/fatal cases were in the high-risk group.
Results date posted	2021 Year 10 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	In the patient cohort, 40% were women, and the median age was 67.2 years. ERCP for biliary diseases and that for pancreatic diseases were 73.2 and 26.8%, respectively.
Participant flow	During the study period, 2976 ERCPs were performed at the three participating hospitals. Among these, 257 ERCPs were excluded for the following reasons: patient age <18 years, 10; comorbid acute pancreatitis, 70; altered gastrointestinal anatomy, 114; anastomosis or fistula, 32; data missing, 19, and others, 12. Therefore, 2719 ERCPs were included in the present study.
Adverse events	none.
Outcome measures	post-ERCP pancreatitis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 12 Day
Date of IRB	2012 Year 10 Month 18 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 09 Month 30 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 05 Month 31 Day

Other
Other related information	Retrospective cohort study. We retrospectively assembled databases of consecutive ERCP procedures performed at Kyoto university Hospital, Kitano Hospital, and Yodogawa Christian Hospital between April 2010 and September 2012.

Management information
Registered date	2019 Year 10 Month 08 Day
Last modified on	2021 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043557