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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038243
Receipt No. R000043557
Scientific Title Prediction rule for post-ERCP pancreatitis
Date of disclosure of the study information 2019/10/14
Last modified on 2020/04/08

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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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 2738
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 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
2020 Year 04 Month 08 Day


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

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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