UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of a standard 19-gauge needle and a new 19-gauge histology needle in diagnostic yields of endoscopic ultrasound-guided fine needle aspiration for solid tumors. Multicenter prospective randomized controlled study
Title of the study (Brief title)	19-gauge histology needle vs 19-gauge standard needle in EUS-FNA
Region	Japan

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

Objectives
Narrative objectives1	To compare diagnostic yields between a standard needle and a new histology needle in EUS-FNA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy in histological analysis
Key secondary outcomes	Yield of visible core Yield of core specimen on histological analysis Success rates of FNA Complication rate of EUS-FNA

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	first pass:A standard 19-gauge FNA neelde 2nd pass:A new 19-gauge histology FNA needle
Interventions/Control_2	first pass:A new 19-gauge histology FNA needle 2nd pass:A standard 19-gauge FNA neelde
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) Patients with a solid mass which is measured more than 20mm and located around upper intestine on imaging studies 2)Patients who understand and willing to give a written informed consent
Key exclusion criteria	1) Patients with bleeding tendency or patients who cannot stop taking antiplatelet agents or anticoagulant agents 2) PS of more than 4 3) possible pregnancy 4) Age<20 5) Patients who are judged inappropriate by a assigned physician
Target sample size	110

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Address	1-1 Yanagido, Gifu, Gifu, Japan
TEL	058-230-6308
Email	takuji@w7.dion.ne.jp

Public contact
Name of contact person	Ichiro Yasuda
Organization	Gifu University Hospital
Division name	First Dept. of Internal Medicine
Address	1-1 Yanagido, Gifu, Gifu, Japan
TEL	058-230-6308
Homepage URL
Email	takuji@w7.dion.ne.jp

Sponsor
Institute	First Dept. of Internal Medicien, Gifu University Hospital
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）、東京大学病院（東京）、東京警察病院（東京）、関東中央病院（東京） Gifu University Hospital (Gifu), Gifu Municipal Hospital (Gifu), University of Tokyo Hospital (Tokyo), Tokyo Metropolitan Police Hospital(Tokyo), Kanto Central Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 04 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry	2014 Year 06 Month 01 Day
Date trial data considered complete	2014 Year 06 Month 01 Day
Date analysis concluded	2015 Year 04 Month 01 Day

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

Management information
Registered date	2013 Year 10 Month 31 Day
Last modified on	2016 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014236