UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017801 |
|---|---|
| Receipt number | 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 08:42:39 |
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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
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
kita335@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020608
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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