UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024393
Receipt number R000013179
Scientific Title The detection of early enhancement image of pericholecystic liver using contrast enhanced ultrasonography (parametric imaging and Time Intencity Curve) in the patients of acute choplecystitis.
Date of disclosure of the study information 2016/10/13
Last modified on 2016/10/13 15:10:24

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Basic information

Public title

The detection of early enhancement image of pericholecystic liver using contrast enhanced ultrasonography (parametric imaging and Time Intencity Curve) in the patients of acute choplecystitis.

Acronym

The detection of early enhancement image of pericholecystic liver using contrast enhanced ultrasonography in the patients of acute choplecystitis.

Scientific Title

The detection of early enhancement image of pericholecystic liver using contrast enhanced ultrasonography (parametric imaging and Time Intencity Curve) in the patients of acute choplecystitis.

Scientific Title:Acronym

The detection of early enhancement image of pericholecystic liver using contrast enhanced ultrasonography in the patients of acute choplecystitis.

Region

Japan


Condition

Condition

acute cholecystitis
(control; not cholecystitis)

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The improvement of the diagnostic power using contrast-enhanced ultrasonography in acute cholecystitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sensitibity, Specificity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Acute cholecystitis group
US examinations were performed with a
diagnostic ultrasound system (TUS-A500;
Toshiba, Tokyo, Japan)
Sonazoid was injected intravenously
(bolus, 0.015 mL/kg) followed by 10 mL
of saline within 10 s.

Interventions/Control_2

Non cholecystitis group
US examinations were performed with a
diagnostic ultrasound system (TUS-A500;
Toshiba, Tokyo, Japan)
Sonazoid was injected intravenously
(bolus, 0.015 mL/kg) followed by 10 mL
of saline within 10 s.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Acute cholecystitis Group
The diagnosis of Acute cholecystitis was
based on the TG13 (Updated Tokyo Guide
lines) criteria.

Non-cholecystitis Group
They undergo CEUS to search for
metastatic liver tumors that could not
be detected by gray-scale US.

Key exclusion criteria

Exclusion criteria

a focal spared area in the LPA to the
gallbladder

portal vein embolism

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hata Jiro

Organization

Kawasaki Medical School

Division name

Departments of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama, Japan

TEL

086-462-1111

Email

ultrajiro@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Hata Jiro

Organization

Kawasaki Medical School

Division name

Departments of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama, Japan

TEL

086-462-1111

Homepage URL


Email

ultrajiro@nifty.com


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

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

2016 Year 10 Month 13 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

2013 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 30 Day

Last follow-up date

2015 Year 09 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 09 Month 29 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 13 Day

Last modified on

2016 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name