UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Title of the study (Brief title)	Randomized controlled trial comparing the usefulness of endoscopic ultrasound processor
Region	Japan

Condition
Condition	Lesions of gastro-intestinal tract, pancreatobiliary and lymph node needed endoscopic ultrasonography(EUS) and EUS-FNA
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	It is aimed to verify which is useful EU-ME2/UCT-260 or SU-1/EG-580UT in EUS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Drawability of EUS
Key secondary outcomes	Insertability and visibility for GI tract. Complication due to this study.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	A doctor who has experienced EUS and EUS-FNA for more than 3 years perform EUS (using EU-ME2) in outpatient or inpatient, and EUS-FNA (using SU-1) in inpatient. Image findings, scope insertability, and visibility for GI tract are evaluated by crossover. EUS will be performed within 4 weeks after consent acquisition and EUS-FNA within 8 weeks after acquiring consent. If there is no problem after the examination, the patient will be discharged.
Interventions/Control_2	A doctor who has experienced EUS and EUS-FNA for more than 3 years perform EUS (using SU-1) in outpatient or inpatient, and EUS-FNA (using EU-ME2) in inpatient. Image findings, scope insertability, and visibility for GI tract are evaluated by crossover. EUS will be performed within 4 weeks after consent acquisition and EUS-FNA within 8 weeks after acquiring consent. If there is no problem after the examination, the patient will be discharged.
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)Men and women over 20 years old at the time we acquire informed consent 2)Patient who require EUS and EUS-FNA clinically(below) Those who suspect the presence of lesions in the gastrointestinal tract, gall bladder / bile duct, pancreas, lymph node and need detailed observation. Those who needs histopathological diagnosis of lesion. Those who judged clinically that EUS / EUS-FNA is necessary other than the above.
Key exclusion criteria	1) Those who cannot obtain informed consent from this research. 2) Women who may be pregnant or have a possibility of pregnancy. 3) Those who judged inappropriate patient as research subject by the research doctor.
Target sample size	40

Research contact person
Name of lead principal investigator	Hajime Isomoto
Organization	Tottori University Hospital
Division name	Department of Gastroenterology
Address	86 Nishi-cho, Yonago, 683-8504, Japan
TEL	0859-38-6527
Email	isomoto@med.tottori-u.ac.jp

Public contact
Name of contact person	Hiroki Koda
Organization	Tottori University Hospital
Division name	Department of Gastroenterology
Address	86 Nishi-cho, Yonago, 683-8504, Japan
TEL	0859-38-6527
Homepage URL
Email	po.polnga.3.negaiwo.xxx@gmail.com

Sponsor
Institute	Tottori University
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	2018 Year 02 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 09 Day
Anticipated trial start date	2016 Year 11 Month 09 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2019 Year 01 Month 01 Day

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

Management information
Registered date	2018 Year 02 Month 19 Day
Last modified on	2019 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035824