UMIN-CTR Clinical Trial

Basic information
Public title	Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Acronym	Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Scientific Title	Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Scientific Title:Acronym	Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Region	Japan

Condition
Condition	Intraductal Papillary Mucinous Neoplasm
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Percentage of pancreatic cysts and IPMN cases discovered after screening
Basic objectives2	Others
Basic objectives -Others	Background Factors of IPMN Cases Discovered by Screening
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Percentage of IPMN found by screening
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	15,859 healthy subjects underwent abdominal ultrasonography (US) between April 2012 and March 2013. In the cyst absent cases, those not achieving the complete image of whole pancreas were excluded. Finally, 9,363 subjects were included in this study. IPMN was defined as more than 5mm pancreatic cyst with the presence of communication to the main pancreatic duct or the presence of multilocular form. Multivariable logistic regression analysis was conducted to identify the risk factors of IPMN in comparison with the subjects without cysts, adjusted by clinical characteristics.
Key exclusion criteria	ago
Target sample size	20000

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Fujita
Organization	Yodogawa Christian Hospital
Division name	Department of Gastroenterology
Zip code	533-0024
Address	1-7-50, Kunijima, Higashi Yodogawa Ku, Osaka, Japan
TEL	0120-364-489
Email	tsuyofuji@gmail.com

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Fujita
Organization	Yodogawa Christian Hospital
Division name	Department of Gastroenterology
Zip code	533-0024
Address	1-7-50, Kunijima, Higashi Yodogawa Ku, Osaka, Japan
TEL	0120-364-489
Homepage URL
Email	tsuyofuji@gmail.com

Sponsor
Institute	Yodogawa Christian Hospital
Institute
Department

Funding Source
Organization	Yodogawa Christian Hospital
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, Higashi Yodogawa Ku, Osaka, Japan
Tel	0120-364-489
Email	tsuyofuji@gmail.com

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	2020 Year 06 Month 30 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	15859
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	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
Date of IRB	2019 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

15,859 healthy subjects underwent abdominal ultrasonography (US) between April 2012 and March 2013. In the cyst absent cases, those not achieving the complete image of whole pancreas were excluded. Finally, 9,363 subjects were included in this study. IPMN was defined as more than 5mm pancreatic cyst with the presence of communication to the main pancreatic duct or the presence of multilocular form. Multivariable logistic regression analysis was conducted to identify the risk factors of IPMN in comparison with the subjects without cysts, adjusted by clinical characteristics.

Management information
Registered date	2020 Year 06 Month 25 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046191