UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of EGJ (esophagogastric junction) function using elastography
Title of the study (Brief title)	Evaluation of EGJ (esophagogastric junction) function using elastography
Region	Japan

Condition
Condition	Gastroesophageal Reflux Disease,functional dyspepsia
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the possibility of esophageal function evaluation by abdominal ultrasonography (US). To examine the usefulness of US in esophageal function evaluation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To reveal the potential evaluation of organic and functional disorders of the esophagogastric junction by abdominal ultrasound elastography
Key secondary outcomes	To verify whether can be evaluated by abdominal ultrasound elastography a therapeutic effect in post-treatment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Case performed upper gastrointestinal endoscopy and abdominal ultrasonography Performance Status 0-2
Key exclusion criteria	Case can't keeping in supine state Case having severe complications or severe mental disorder
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Address	65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL	+81-52-744-2602
Email	hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person	Suhara Hiroki
Organization	Nagoya University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Address	65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL	+81-52-744-2602
Homepage URL
Email	h-suhara@med.nagoya-u.ac.jp

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

Funding Source
Organization	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry	2017 Year 01 Month 01 Day
Date trial data considered complete	2017 Year 07 Month 20 Day
Date analysis concluded	2017 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The number of CS as determined by US-EG in 30s was significantly lower in the RE group as compared with the non-RE group 6.0(5.5-6.7) vs 8.6 (6.6-10.0) p>0.00001.
Other related information	The esophagogastric junction using elastography based subcutaneous fat and liver consider the dfference and the ratio in hardness. Change of hardness in each diseases records shape, space and frequency of the waveform prospectively.

Management information
Registered date	2015 Year 01 Month 07 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018740