UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004191
Receipt number R000004856
Scientific Title Prospective study for branch duct intraductal papillary mucinous neoplasms
Date of disclosure of the study information 2010/10/01
Last modified on 2012/04/19 23:01:46

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Basic information

Public title

Prospective study for branch duct intraductal papillary mucinous neoplasms

Acronym

Prospective study forBD-IPMNs

Scientific Title

Prospective study for branch duct intraductal papillary mucinous neoplasms

Scientific Title:Acronym

Prospective study forBD-IPMNs

Region

Japan


Condition

Condition

Intraductal papillary mucinous neoplasm(IPMN)

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Natural history of BD-IPMN

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Rate of progression

Key secondary outcomes

Presence of new IPMN lesions, pancreatic cancers, extrapancreatic malignancies. How to progress BD-IPMNs


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

1: diagnosed of BD-IPMN
2: diameter of MPD <10mm and height of mural nodule <5mm
3: any age and both sex is OK
4: Receive informed consent

Key exclusion criteria

1: No informed consent
2: diameter of MPD &#8805;10mm and/or height of mural nodule &#8805;5mm
3: allergy for contrast
4: don't perform MRI
5: doctors judgement is not appropriate for this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Chiba

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-4319

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuzo Kodama

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-4319

Homepage URL


Email



Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



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


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

2010 Year 10 Month 01 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

Open public recruiting

Date of protocol fixation

2010 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2016 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 03 Month 01 Day

Date trial data considered complete

2017 Year 03 Month 01 Day

Date analysis concluded

2017 Year 04 Month 01 Day


Other

Other related information

To identify the natural history of BD-IPMN, we'll perform long time follow up.


Management information

Registered date

2010 Year 09 Month 10 Day

Last modified on

2012 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name