UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of contrast-enhanced endoscopic ultrasonography for diagnosing pancreatic tumor
Title of the study (Brief title)	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	Takuji Iwashita
Organization	Gifu University Faculty of Medicine
Division name	Department of gastroenterology
Address	1-1 Yanagido,Gifu,Gifu
TEL	058-230-6000
Email	takuji@w7.dion.ne.jp

Public contact
Name of contact person	Takuji Iwashita
Organization	Gifu University Faculty of Medicine
Division name	Department of gastroenterology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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