UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029979
Receipt number R000034239
Scientific Title Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.
Date of disclosure of the study information 2017/12/01
Last modified on 2022/11/20 14:51:26

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Basic information

Public title

Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.

Acronym

Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.

Scientific Title

Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.

Scientific Title:Acronym

Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.

Region

Japan


Condition

Condition

Dijestive disease

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify pancreatic exocrine function in digestive disease cases.

Basic objectives2

Others

Basic objectives -Others

To clarify pancreatic exocrine function among
each digestive diseases and it's sequential change.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pancreatic exocrine function

Key secondary outcomes



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

People with digestive disorder cases and healthy volunteers who understand the examination contents and obtain consent to the examination.

Key exclusion criteria

People who do not accept the examination.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Watanabe

Organization

Shinshu University

Division name

Department of Gastroenterology

Zip code

3908621

Address

3-1-1, Asahi, Matsumoto City, Nagano Prefecture

TEL

09044780592

Email

wat1400@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Watanabe

Organization

Shinshu University

Division name

Department of Gastroenterology

Zip code

3908621

Address

3-1-1, Asahi, Matsumoto City, Nagano Prefecture

TEL

09044780592

Homepage URL


Email

wat1400@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Company Limited
Takeda reserch support

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University Ethics Committee

Address

3-1-1, Asahi, Matsumoto City, Nagano Prefecture

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp


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 12 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

No longer recruiting

Date of protocol fixation

2017 Year 09 Month 05 Day

Date of IRB

2017 Year 09 Month 05 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2022 Year 09 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational research; We assess pancreatic exocrine function of dijestive disease patients using fecal elastase. And if possible, we assess regulary after first examination.


Management information

Registered date

2017 Year 11 Month 15 Day

Last modified on

2022 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name