UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective clinical study of histological diagnostic accuracy on EUS-guided FNA using 20G FNA needle
Title of the study (Brief title)	Diagnostic yield of 20G FNA needle on EUS-guided FNA
Region	Japan

Condition
Condition	Pancreatic tumor
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate diagnostic accuracy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histological diagnostic accracy
Key secondary outcomes

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	ProCore 20G FNA needle
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) over 20 years old 2)having pancreatic tumor 3)Performance status is under 2 4)Patients who have no serious complications 5)EUS-FNA is needed 6)Informed consent is obtained
Key exclusion criteria	1)Risk of EUS-FNA such as easy bleeding 2)Patient refuse to undergo EUS-FNA 3)other reason according to endoscopist's opinions
Target sample size	50

Research contact person
Name of lead principal investigator	Takeshi Ogura
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7 Daigaku-machi, Takatsuki-shi, Osaka 569-8686, Japan
TEL	0726-83-1221
Email	oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person	Takeshi Ogura
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7 Daigaku-machi, Takatsuki-shi, Osaka 569-8686, Japan
TEL	0726-83-1221
Homepage URL
Email	oguratakeshi0411@yahoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
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 05 Month 27 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025931