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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025192
Receipt No. 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

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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
Email 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
Email takuji@w7.dion.ne.jp

Sponsor
Institute Gifu University Faculty of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028980

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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