UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Title of the study (Brief title)	Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Region	Japan

Condition
Condition	Tumor lesions
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Adequate sample for histological diagnosis
Basic objectives2	Others
Basic objectives -Others	Accuracy rate
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adequate sample for histological diagnosis
Key secondary outcomes	Accuracy rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	19G Fine needle
Interventions/Control_2	21G Fine needle
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	Patients who are needed to perform EUS-FNA for diagnosis
Key exclusion criteria	Under 20 year old, pregnancy
Target sample size	200

Research contact person
Name of lead principal investigator	Takeshi Ogura
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7 Daigakuchou, Takatsukishi, Osaka
TEL	+81-527626111
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 Daigakuchou, Takatsukishi, Osaka
TEL	+81-527626111
Homepage URL
Email	oguratakeshi0411@yahoo.co.jp

Sponsor
Institute	Takeshi Ogura
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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 30 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	2015 Year 11 Month 17 Day
Last modified on	2017 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022907