UMIN-CTR Clinical Trial

Basic information
Public title	The risk factors for progression to chronic pancreatitis in patients with past history of acute pancreatitis: a retrospective analysis based on mechanistic definition
Acronym	The risk factors for progression to chronic pancreatitis in patients with past history of acute pancreatitis: a retrospective analysis based on mechanistic definition
Scientific Title	The risk factors for progression to chronic pancreatitis in patients with past history of acute pancreatitis: a retrospective analysis based on mechanistic definition
Scientific Title:Acronym	The risk factors for progression to chronic pancreatitis in patients with past history of acute pancreatitis: a retrospective analysis based on mechanistic definition
Region	Japan

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

Objectives
Narrative objectives1	To investigated risk factors for progression to chronic pancreatitis(CP)in patients with past history of acute pancreatitis(AP).
Basic objectives2	Others
Basic objectives -Others	To investigated risk factors for progression to chronic pancreatitis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to examine the differences in AP severity, and the etiology of progression and non-progression to CP between 2 years.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients were hospitalized with AP at our institution between April 2009 and March 2017.
Key exclusion criteria	panatic cancer
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Yamamiya
Organization	Dokkyo Medical University School of Medicine
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
TEL	0282872147
Email	akira-y@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yamamiya
Organization	Dokkyo Medical University School of Medicine
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
TEL	0282872147
Homepage URL
Email	akira-y@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Dokkyo Medical University School of Medicin
Address	880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
Tel	0282872147
Email	akira-y@dokkyomed.ac.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

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 27 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 27 Day
Last follow-up date	2026 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 06 Month 26 Day
Last modified on	2021 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051014