UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035084
Receipt number R000039906
Scientific Title The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography
Date of disclosure of the study information 2018/11/30
Last modified on 2021/08/28 07:04:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography

Acronym

The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography

Scientific Title

The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography

Scientific Title:Acronym

The diagnostic ability for gastrointestinal and hepatobiliary-pancreatic disease by ultrasound including ultrasound elastography

Region

Japan


Condition

Condition

Gastrointestinal and hepatobiliary-pancreatic disease

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the diagnostic ability of gastrointestinal and hepatobiliary-pancreatic disease using ultrasonography

Basic objectives2

Others

Basic objectives -Others

The diagnostic accuracy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To clarify the consistency between ultrasonic diagnosis and final diagnosis of gastrointestinal and hepatobiliary-pancreatic disease.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with histopathological diagnosis

Key exclusion criteria

Patients without histopathological diagnosis

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroko Iijima

Organization

Hyogo College of Medicine

Division name

Ultrasound Imaging Center

Zip code


Address

1-1, Mukogawacho, Nishinomiya, Hyogo

TEL

0798-45-6316

Email

hiroko-i@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Nishimura

Organization

Hyogo College of Medicine

Division name

Ultrasound Imaging Center

Zip code


Address

1-1, Mukogawacho, Nishinomiya, Hyogo

TEL

0798-45-6316

Homepage URL


Email

tk-nishimura@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2018 Year 11 Month 30 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

Terminated

Date of protocol fixation

2017 Year 10 Month 19 Day

Date of IRB

2017 Year 10 Month 19 Day

Anticipated trial start date

2017 Year 10 Month 19 Day

Last follow-up date

2021 Year 08 Month 22 Day

Date of closure to data entry

2021 Year 08 Month 22 Day

Date trial data considered complete

2021 Year 08 Month 22 Day

Date analysis concluded

2021 Year 08 Month 22 Day


Other

Other related information

Study subjects will include not only malignant tumors but also begnin tumor and inflammatory disease.


Management information

Registered date

2018 Year 11 Month 30 Day

Last modified on

2021 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name