UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Histologic diagnosis endoscopic ultrasound needles with and without franseen design :A randomized controlled trial
Title of the study (Brief title)	A randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration
Region	Japan

Condition
Condition	Cases which needs histlogical diagnosis by EUS-FNA
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare histological diagnosis ability of with and without franseen needle
Basic objectives2	Others
Basic objectives -Others	quantitiy of sample
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy for histrogical diagnosis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	EUS-FNA using standard needle
Interventions/Control_2	EUS-FNA using franseen 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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	case which needs EUS-FNA
Key exclusion criteria	cystic disease
Target sample size	40

Research contact person
Name of lead principal investigator	Mitsuhiro Kida
Organization	Kitasato university medical center
Division name	Department of gastroenterology
Address	6-100 Arai kitamoto city Saitama
TEL	0485931212
Email	uehara@kitasato-u.ac.jp

Public contact
Name of contact person	Kazuho Uehara
Organization	Kitasato university medical center
Division name	Department of gastroenterology
Address	6-100 Arai kitamoto city Saitama
TEL	0485931212
Homepage URL
Email	uehara@kitasato-u.ac.jp

Sponsor
Institute	Kitasato university medical center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 10 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	2018 Year 06 Month 17 Day
Last modified on	2018 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037655