UMIN-CTR Clinical Trial

Basic information
Public title	Evalutation of the patients with localized stricture of MPD without obvious mass in the pancreas
Acronym	Pancreatic cancer study
Scientific Title	Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer
Scientific Title:Acronym	Study for the early detection of pancreatic cancer
Region	Japan

Condition
Condition	Patients with localized MPD stricture without obvious mass in pancreas
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to find new imaging findings leading to the early detection of pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reading computed tomography, magnetic resonance imaging, and endoscopic ultrasonography image.
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	Patients with MPD stricture
Key exclusion criteria	Patients with obvious pancreatic mass Patients with chronic pancreatitis Patients with post pancreatic surgery Patients with pancreatic injury
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Kurita
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name	Department of Gastroenterology and Hepatology
Zip code	530-8480
Address	2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL	06-6131-2662
Email	kuritaaki1976@gmail.com

Public contact
Name of contact person	1st name Akira Middle name Last name Kurita
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name	Department of Gastroenterology and Hepatology
Zip code	530-8480
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL	06-6131-2662
Homepage URL
Email	kuritaaki1976@gmail.com

Sponsor
Institute	Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Institute
Department

Funding Source
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute.
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	Medical Ethics Committee of Kitano Hospital
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
Tel	06-6131-2662
Email	rinshou@kitano-hp.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	公益財団法人田附興風会医学研究所北野病院

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 01 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	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 01 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective analysis

Management information
Registered date	2020 Year 02 Month 28 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045193