UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025993
Receipt number R000029880
Scientific Title Examination of preoperative diagnostic method for resectable pancreatic cancer
Date of disclosure of the study information 2017/02/10
Last modified on 2017/02/03 16:47:56

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Basic information

Public title

Examination of preoperative diagnostic method for resectable pancreatic cancer

Acronym

Preoperative diagnostic examination for pancreatic cancer

Scientific Title

Examination of preoperative diagnostic method for resectable pancreatic cancer

Scientific Title:Acronym

Preoperative diagnostic examination for pancreatic cancer

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the preoperative diagnostic method for resectable pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

・The diagnostic ability of various preoperative examination for resectable pancreatic cancer

Key secondary outcomes

・The influences of various preoperative examination for curability of surgery and postoperative prognosis(recurrence, peritoneal dissemination, survival time)
・Adverse event rate of various diagnostic method


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

Patients who underwent preoperative examination for solid pancreatic tumor between January 2005 and December 2015 at Gifu University Hospital and related facilities.

Key exclusion criteria

Patients with a history of gastric surgery.

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuji Iwashita

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu city

TEL

058-230-6308

Email

takuji@w7.dion.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akinori Maruta

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu city

TEL

058-230-6308

Homepage URL


Email

mrak5844@yahoo.co.jp


Sponsor or person

Institute

Gifu 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

2017 Year 02 Month 10 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

Completed

Date of protocol fixation

2017 Year 02 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate patients who underwent preoperative examination for solid pancreatic tumor between January 2005 and December 2015 at Gifu University Hospital and related facilities,retrospectively.


Management information

Registered date

2017 Year 02 Month 03 Day

Last modified on

2017 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029880


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name