UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021474
Receipt number R000024762
Scientific Title Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas
Date of disclosure of the study information 2016/05/14
Last modified on 2017/02/22 13:41:27

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Basic information

Public title

Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas

Acronym

Analysis of a factor associated with a Lymph node metastasis in the operation case IPMN

Scientific Title

Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas

Scientific Title:Acronym

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

1st name
Middle name
Last name Atsuhiro Masuda

Organization

Kobe University Graduate School of Medicine

Division name

Gastroenterology

Zip code


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

1st name
Middle name
Last name Kodai Yamanaka

Organization

Kobe University Graduate School of Medicine

Division name

Gastroenterology

Zip code


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 or person

Institute

Kobe University Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Main results already published

Date of protocol fixation

2016 Year 03 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name