UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Title of the study (Brief title)	A prospective surveillance study of brunch duct IPMN.
Region	Japan

Condition
Condition	Branch duct intraductal mucinous papillary neoplasm of the pancrease(BD-IPMN).
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the natural history of BD-IPMN.
Basic objectives2	Others
Basic objectives -Others	To evaluate the incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPMN.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The progression of BD-IPMN
Key secondary outcomes	The incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPM.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed as BD-IPMN, which has a communication with MPD detected by MRCP or EUS or ERCP. 2) Patients having fish-eye appearance of duodenal papilla or apparent mucin in pancreatic duct found in ERCP. 3) Patients over 20 years 4) Patients accepted informed consent
Key exclusion criteria	1) MPD diameter more than 10mm 2) mural nodule more than 5mm 3) pancreatic stones and dilated or stenotic MPD induced by chronic pancreatitis 4) concomitant with pancreatic ductal adenocarcinoma at the diagnosis 5) considered ineligible by attendant doctors
Target sample size	400

Research contact person
Name of lead principal investigator	Mitsuhiro Kida
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL	042-778-8111
Email	m-kida@kitasato-u.ac.jp

Public contact
Name of contact person	Tomohisa Iwai
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL	042-778-8111
Homepage URL
Email	t-iwai@kitasato-u.ac.jp

Sponsor
Institute	Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology Kitasato University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北里大学東病院　Kitasato University East Hospital 北里大学病院　Kitasato University Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 24 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry	2018 Year 11 Month 01 Day
Date trial data considered complete	2018 Year 11 Month 01 Day
Date analysis concluded	2018 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A single-center prospective cohort study

Management information
Registered date	2012 Year 11 Month 08 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010896