UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A new functional endoscopy for gastroesophageal reflux disease (GERD) for hiatal hernia cases: a prospective clinical trial on the usefulness of Endoscopic pressure study integrated system (EPSIS)
Title of the study (Brief title)	The usefulness of a new functional endoscopy (EPSIS) in the diagnosis of GERD for hiatus hernia
Region	Japan

Condition
Condition	hiatal hernia gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness of EPSIS for GERD with hiatal hernia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intra-gastric pressure max (IGP max)
Key secondary outcomes	The pattern of intra-gastric pressure Scope holding time % (SHT %) Scope holding sign (SHS) Scope holding position (SHP) Synchronicity and duration of intra-gastric pressure change and belching Peristalsis Cardiac opening (CO) Sliding hernia (SH)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with hiatus hernia.
Key exclusion criteria	Patients with pregnant Patients who has severe complications(Heart disease, renal disease, liver disease and lung disease) Patients with psychiatric disorders Patients without informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	Haruhiro Inoue
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL	03-6204-6000
Email	haruinoue777@yahoo.co.jp

Public contact
Name of contact person	Masaki Ominami
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive disease center
Address	5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL	03-6204-6000
Homepage URL
Email	komesoudoh@yahoo.co.jp

Sponsor
Institute	Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization	Showa University Koto Toyosu Hospital
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	2020 Year 08 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 03 Day
Anticipated trial start date	2017 Year 09 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	Based on the information obtained in the examination record of this study and the questionnaire, the evaluation items of the group without GERD symptoms (F scale: less than 8) and the group with GERD symptoms (F scale: 8 or more) were statistically .

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032724