UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for diagnosing gallbladder diseases: A prospective study
Title of the study (Brief title)	Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for gallbladder diseases
Region	Japan

Condition
Condition	Gallbladder neoplastic lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) diagnosability with contrast-enhanced ultrasonography (CH-US) diagnosability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnosabiligy of CH-EUS, or CH-US
Key secondary outcomes	To compare the following items between CH-EUS and CH-US, or before and after contrast enhance of EUS, or US. 1. evauation of gallbladder cancer invasion depth. 2. diagnosability To clarify diagnosable patients only by CH-US.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	use of ultrasonography enhance agent Sonazoid (Daiichisankyo, Tokyo, Japan)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Men and Women older than twenty years old. 2. Patients observed neoplastic lesion with major axis larger than 10 mm by CT, or B mode ultrasonography. For example, gallbladder cancer, gallbladder adenoma, adenomyomatosis, gallbladder polyps). 3. Function of major organs are good. 4. Patients who give a written concent for this study.
Key exclusion criteria	1. very low performance status (3-4) 2. Patients who are not performed surgery or endoscopy because of serious heart failure, or serious renal failure, or cerebrovascular diseases, etc. 3. Patients who were judged incompatible by attendig doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiromasa Ohira
Organization	Fukushima medical university, School of Medicine
Division name	Gastroenterology and Rheumatology
Address	1 Hikarigaoka, Fukushima
TEL	024-547-1202
Email	intmed2@fmu.ac.jp

Public contact
Name of contact person	Mitsuru Sugimoto
Organization	School of Medicine, Fukushima medical university
Division name	Gastroenterology and Rheumatology
Address	1 Hkarigaoka, Fukushima
TEL	024-547-1202
Homepage URL
Email	kita335@fmu.ac.jp

Sponsor
Institute	Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine
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	2015 Year 06 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 06 Month 04 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 03 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020608