UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hata Jiro
Organization	Kawasaki Medical School
Division name	Departments of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Email	ultrajiro@nifty.com

Public contact
Name of contact person	Hata Jiro
Organization	Kawasaki Medical School
Division name	Departments of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	ultrajiro@nifty.com

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013179