UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter prospective comparative crossover trial of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Title of the study (Brief title)	Comparative crossover trial of EUS-FNA with and without stylet
Region	Japan

Condition
Condition	Pancreatic solid masses detected by imaging examination
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate histological tissue acquisition rate, quality of tissue, accuracy between EUS-FNA with and without stylet
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy
Key secondary outcomes	Cellularity of tissue obtained Quality of tissue obtained Adequate quality

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	At first and third aspiration,EUSFNA with stylet is performed. At second and forth aspiration, EUS-FNA without stylet is performed.
Interventions/Control_2	At first and third aspiration,EUSFNA without stylet is performed. At second and forth aspiration, EUS-FNA with stylet is performed.
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 solid pancreatic mass, which can be punctured from stomach or duodenum using 22G safely. 2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria	1) Cases in Perfomance status 4 2)Cases with sever complication in other organs except original disease (ASA classification more than 3) 3)Cases having impossibility of cessation of anticoagulant 4)Cases with pregnancy or suspect of pregnancy 5)Cases having difficulty in endoscopic approach 6)Cases with definite diagnosis by another biopsy 7) Cases having difficulty in visualization of mass on EUS 8)Cases judged by principal investigator to be inadequate as subjects
Target sample size	100

Research contact person
Name of lead principal investigator	Takao Itoi
Organization	Tokyo Medical University
Division name	Department of Gastroenterology and Hepatology
Address	6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	itoitakao@gmail.com

Public contact
Name of contact person	Shuntaro Mukai
Organization	Tokyo Medical University
Division name	Department of Gastroenterology and Hepatology
Address	6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	maezora1031@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center Hospital Endoscopy division
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 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 20 Day
Anticipated trial start date	2015 Year 07 Month 20 Day
Last follow-up date	2017 Year 07 Month 20 Day
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 07 Month 20 Day
Last modified on	2018 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021254