UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of the natural history of pancreatic cyst including branch duct type intraductal papillary mucinous neoplasms of the pancreas
Acronym	A prospective study of the natural history of pancreatic cyst including branch duct type IPMN
Scientific Title	A prospective study of the natural history of pancreatic cyst including branch duct type intraductal papillary mucinous neoplasms of the pancreas
Scientific Title:Acronym	A prospective study of the natural history of pancreatic cyst including branch duct type IPMN
Region	Japan

Condition
Condition	Non-specific pancreatic cyst and branch duct type intraductal papillary mucinous neoplasm of the pancreas
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Branch duct type IPMN (BD-IPMN), which is representative cystic lesion of the pancreas, is associated with the pancreatic carcinogenesis, such as a malignant transformation of IPMN itself and a concomitant onset of pancreatic ductal adenocarcinoma. Though the small cysts of the pancreas sometimes cannot be classified with the specific cystic disease of the pancreas by imaging studies, some clinical and pathological reports indicate that most of those "non-specific" cysts of the pancreas are biologically similar with IPMN. Based on this insight, the recommendation of the clinical examinations for small cystic lesion including small BD-IPMN in every 2-3 years by the international guideline may be inadequate. In response to the above, since September 2012 in our medical center, the imaging examinations in every 6 months have been performed for all the follow-up patients with BD-IPMN or non-specific pancreatic cyst. To estimate the risk of pancreatic carcinogenesis in those subjects and the contribution to the prognosis by the close follow-up, we designed a long-term and prospective cohort study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of pancreatic carcinogenesis in patients with non-specific pancreatic cyst or branch duct type intraductal papillary mucinous neoplasm of the pancreas
Key secondary outcomes	1) Prognosis of the subjects 2) The rate of progression of the pancreatic lesion

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	The patients with BD-IPMN or non-specific pancreatic cyst.
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	600

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	2012 Year 09 Month 28 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective cohort 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=R000019697