UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas
Title of the study (Brief title)	Analysis of a factor associated with a Lymph node metastasis in the operation case IPMN
Region	Japan

Condition
Condition	Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find the factors associated with lymph node metastasis of Invasive IPMN
Basic objectives2	Others
Basic objectives -Others	To find the factors associated with lymph node metastasis of Invasive IPMN
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To analyze the association between patient's background characteristics and lymph node metastasis of Invasive IPMN using chi-square test
Key secondary outcomes	1.For factors which are significant by chi-square test, we will conduct multivariate logistic regression analysis. 2.For factors which are significant by chi-square test, we will conduct Kaplan-Meier estimation. Significance level will be evaluated by the log-rank test.

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	Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas which was operated by kobe University Hospital between June 2000 to August 2015
Key exclusion criteria	The patient which was complicated by other cancer
Target sample size	47

Research contact person
Name of lead principal investigator	Atsuhiro Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Address	a7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	Kodai Yamanaka
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan, 650-0017
TEL	078-382-6305
Homepage URL
Email	Yamakou@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design Retrospective observational study Subjects Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas which was operated by kobe University Hospital between June 2000 to August 2015

Management information
Registered date	2016 Year 03 Month 15 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024762