UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030735 |
|---|---|
| Receipt number | R000034581 |
| Scientific Title | Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2019/07/12 10:09:40 |
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Basic information
Public title
Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease
Acronym
A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease
Scientific Title
Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease
Scientific Title:Acronym
A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease
Region
| Japan |
Condition
Condition
Pancreas tumor, Chronic pancreatitis, Autoimmune pancreatitis, Gallblader polyp, Biliary tract tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate whether contrast-enhanced endoscopic ultrasonography can provide a reliable diagnosis for pancreatobbiliary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate whether contrast enhanced endoscopic ultrasonography can provide a reliable diagnosis for pancreatobbiliary disease, we compare the diagnostic accuracy of contrast enhanced endoscopic ultrasonography with enhanced conputed tomography, magnetic resonance imaging, and endoscopic ultrasonography without perflubutane
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Contrast enhanced endoscopic ultrasonography using perflubutane
Interventions/Control_2
MRI
Interventions/Control_3
enhanced CT
Interventions/Control_4
endoscopic ultrasonography without perflubutane
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who are suspected pacreatobiliary disease by ohter modality(CT, US, MRI).
2.Performance status; 0,1,2.
3.Patients who got ingormed consent.
Key exclusion criteria
1.Patients with allergy to egg.
2.Patients with arteriovenous shunt in cardia.
3.Patients woth severe cardiac disease.
4.Patients with sebere lung disorder.
5.Female patients with pregnacy or nursing.
6.Patients with mental aliments who cannot sign up for this clinical trial.
7.Patients with adverse events to perflubutane including minimal side effects.
8.Inadequate patients to participate in this study, in the judgement of an attending doctor or inspection physician.
Target sample size
786
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
0334331111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Chiba |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
0334331111
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
Department of Endoscopy
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、東京慈恵会医科大学葛飾医療センター（東京都）、東京慈恵会医科大学附属第三病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034581
