UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of appropriate follow-up interval for high-risk group of branch duct type intraductal papillary mucinous neoplasms of the pancreas
Acronym	A prospective study of appropriate follow-up interval for high-risk group of branch duct type IPMN
Scientific Title	A prospective study of appropriate follow-up interval for high-risk group of branch duct type intraductal papillary mucinous neoplasms of the pancreas
Scientific Title:Acronym	A prospective study of appropriate follow-up interval for high-risk group of branch duct type IPMN
Region	Japan

Condition
Condition	Branch duct type intraductal papillary mucious neoplasms of the pancreas
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The validity of a follow-up interval for high-risk group of branch duct type IPMN
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Stages of invasive cancers derived from IPMN
Key secondary outcomes	1)Prognosis 2)Factors associated with an onset of invasive cancers derived from IPMN 3)Progression of IPMN

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	Branch duct type IPMN greater than 30 mm in size
Key exclusion criteria	1) A concurrence of pancreatic malignancies at the time of diagnosis of IPMN. 2) The contraindication or rejection for the imaging examinations by EUS or MRCP. 3) The patients from whom the informed consent cannot be obtained. 4) The patients who are judged inappropriate for the participation for this study by the attending doctor.
Target sample size	155

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Koshita
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
TEL	+81-22-252-1111
Email	skoshita@openhp.or.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Koshita
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
TEL	+81-22-252-1111
Homepage URL
Email	skoshita@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
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	Sendai City Medical Center
Address	5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
Tel	+81-22-252-1111
Email	skoshita@openhp.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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 31 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	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 01 Day
Date of IRB	2013 Year 03 Month 29 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Historical controlled study

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2019 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019717