UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025192 |
|---|---|
| Receipt number | R000028980 |
| Scientific Title | Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor |
| Date of disclosure of the study information | 2016/12/08 |
| Last modified on | 2016/12/08 23:00:31 |
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Basic information
Public title
Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor
Acronym
Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor
Scientific Title
Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor
Scientific Title:Acronym
Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor
Region
| Japan |
Condition
Condition
Pancreatic tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to assess benign and malignant difference in pancreatic tumor by using contrast-enhanced endoscopic ultrasonography and to assess the best differentiation method of benign and malignant lymph nodes by creating TIC(time intensity curve).
Finally,the aim of this study is to improve sensitivity,specificity,false negative rate by only using contrast-enhanced endoscopic ultrasonography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability for benign and malignant lymph nodes by using qualitative evaluation of contrast-enhanced endoscopic ultrasonography
Key secondary outcomes
To assess the usefulness of quantitative evaluation by using TIC analysis
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
| Device,equipment |
Interventions/Control_1
Contrast-enhanced 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
Patient who indicate pancreatic tumor tract by imaging study
Patient who intend to endoscopic ultrasound-guided fine-needle aspiration for pancreatic tumor
Written informed consent
ECOG performance status = 0-2
Key exclusion criteria
Inapropriate to perform endoscopic ultrasonography
Blood coagulation disorder(PT-INR>1.5)or fewer platelets(<50,000mm3)
Patient who take anticoagulant or antiplatelet drug cannot stop these drugs
Allergy to iodine or eggs
Chances of pregnancy
Failure of other organs(ASA:Grade 3,4)
Inability to obtain informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Faculty of Medicine
Division name
Department of gastroenterology
Zip code
Address
1-1 Yanagido,Gifu,Gifu
TEL
058-230-6000
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Faculty of Medicine
Division name
Department of gastroenterology
Zip code
Address
1-1 Yanagido,Gifu,Gifu
TEL
058-230-6000
Homepage URL
takuji@w7.dion.ne.jp
Sponsor or person
Institute
Gifu University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
岐阜大学医学部附属病院（岐阜県）、岐阜市民病院（岐阜県）、岐阜県総合医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 12 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
