UMIN-CTR Clinical Trial

Basic information
Public title	A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Acronym	A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Scientific Title	A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Scientific Title:Acronym	A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Region	Japan

Condition
Condition	Pancreatic cysts less than 10 mm in size
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)
Basic objectives2	Others
Basic objectives -Others	To elucidate the natural history of pancreatic cysts less than 10 mm in size
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)
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 with pancreatic cysts less than 10 mm in size on MRI
Key exclusion criteria	1) Patients with pancreatic cysts 10 mm or more in size 2) Patients with pancreatic cysts less than 10 mm in size concomitant with pancreatic cysts 10 mm or more in size 3) A concurrence of pancreatic malignancies at the time of registration 5) Patients from whom informed consent cannot be obtained 6) Patients who are judged inappropriate for the participation for this study by attending doctors
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Tanno
Organization	IMS Sapporo Digestive Disease Center General Hospital
Division name	Department of Gastroenterology
Zip code	063-0842
Address	1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL	011-611-1391
Email	satoshtanno@gmail.com

Public contact
Name of contact person	1st name Satoshi Middle name Last name Tanno
Organization	IMS Sapporo Digestive Disease Center General Hospital
Division name	Department of Gastroenterology
Zip code	063-0842
Address	1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL	011-611-1391
Homepage URL
Email	satoshtanno@gmail.com

Sponsor
Institute	Japan Pancreas Society
Institute
Department

Funding Source
Organization	Japan Pancreas Society
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	IMS Sapporo Digestive Disease Center General Hospital
Address	1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
Tel	011-611-1391
Email	satoshtanno@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	2016 Year 07 Month 19 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	1131
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	2016 Year 06 Month 30 Day
Date of IRB	2016 Year 06 Month 16 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A multicenter prospective cohort study

Management information
Registered date	2016 Year 07 Month 18 Day
Last modified on	2019 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026620