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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017801
Receipt No. R000020608
Scientific Title Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for diagnosing gallbladder diseases: A prospective study
Date of disclosure of the study information 2015/06/04
Last modified on 2016/07/27

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Basic information
Public title Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for diagnosing gallbladder diseases: A prospective study
Acronym Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for gallbladder diseases
Scientific Title Contrast-enhanced harmonic endoscopic ultrasonography vs contrast-enhanced harmonic ultrasonography for diagnosing gallbladder diseases: A prospective study
Scientific Title:Acronym 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.

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

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
1st name
Middle name
Last name Hiromasa Ohira
Organization Fukushima medical university, School of Medicine
Division name Gastroenterology and Rheumatology
Zip code
Address 1 Hikarigaoka, Fukushima
TEL 024-547-1202
Email intmed2@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Sugimoto
Organization School of Medicine, Fukushima medical university
Division name Gastroenterology and Rheumatology
Zip code
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

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)

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
2015 Year 06 Month 04 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
2015 Year 06 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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