UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011124 |
|---|---|
| Receipt number | R000013035 |
| Scientific Title | Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of pancreatic tumors: a prospective multicenter study |
| Date of disclosure of the study information | 2013/07/20 |
| Last modified on | 2020/06/01 19:13:33 |
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Basic information
Public title
Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of pancreatic tumors: a prospective multicenter study
Acronym
Utility of contrast-enhanced harmonic endoscopic ultrasonography
Scientific Title
Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of pancreatic tumors: a prospective multicenter study
Scientific Title:Acronym
Utility of contrast-enhanced harmonic endoscopic ultrasonography
Region
| Japan |
Condition
Condition
Pancreatic tumors
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 the diagnostic accuracy of contrast-enhanced harmonic endoscopic ultrasonography for pancreatic tumors by comparing with the other modalities.
A multicenter cohort study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the diagnostic ability of contrast-enhanced harmonic endoscopic ultrasonography in diagnosing pancreatic tumors.
To compare the diagnostic accuracy of contrast-enhanced harmonic endoscopic ultrasonography with that of tissue harmonic endoscopic ultrasonography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Contrast-enhanced harmonic endoscopic ultrasonography
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pancreatic mass of 3cm or less to be depicted by conventional endoscopic ultrasonography
Written informed consent
ECOG performance status = 0-2
Key exclusion criteria
Inapropriate to perform endoscopic ultrasonography
Impossible to perform endoscopy
Surgically altered digestive tract
Failure of other organs (ASA: Grade 3, 4)
Allergy to iodine or eggs
Renal failure
Inability to obtain informed consent
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kitano |
| Middle name | |
| Last name | Masayuki |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Omoto |
Organization
Kindai University Faculty of Medicine
Division name
gastroenterology and hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
shunsuke.oomoto@gmail.com
Sponsor or person
Institute
Study Group for Contrast-enhanced Harmonic Endoscopic Ultrasonography
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine Clinical Research Center
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
東北大学医学部附属病院（宮城県）、横浜市立大学総合医療センター（神奈川県）、山梨大学医学部附属病院（山梨県）、大阪府立成人病センター（大阪府）、近畿大学医学部附属病院（大阪府）、神戸大学医学部附属病院（兵庫県）、岡山大学医学部附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 20 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013035
