UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of clinical use of EUS-elastography using Shear Wave Measurement (SWM) for gastroenterological disorders.
Title of the study (Brief title)	N-EUS-SWE study
Region	Japan

Condition
Condition	Abdominal organs
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the tissue elasticity of abdominal organs by EUS-shear wave elastography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The tissue elasticity value of each organs, each diseases
Key secondary outcomes	Incidence of complication of EUS-SWE Correlation tissue elasticity with organ function Change of tissue elasticity by intervention Diagnostic performance of EUS-SWE of each diseases

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Observation by Endoscopic ultrasonography
Interventions/Control_2
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 who need to undergo EUS observation or EUS intervention for abdominal diseases. 2)Patients who provided written informed consent
Key exclusion criteria	Patients who are not indicated for endoscopy. 1)Patients with poor general condition 2)Patients with gastrointestinal perforation 3)Patients with strangulated ileus 4)Patients with severe comorbidities 5)Patients with mental disorder 6)Patients judged as inappropriate by attendant doctor
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2602
Email	hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person	Eizaburo Ohno
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2602
Homepage URL
Email	eono@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine,Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hitachi, Ltd. Healthcare Ultrasound R&D Center
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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 01 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	2017 Year 07 Month 04 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032140