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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027448
Receipt No. R000028169
Scientific Title Functional endoscopy for hiatal hernia
Date of disclosure of the study information 2017/05/23
Last modified on 2020/05/25

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Basic information
Public title Functional endoscopy for hiatal hernia
Acronym Functional endoscopy for hiatal hernia
Scientific Title Functional endoscopy for hiatal hernia
Scientific Title:Acronym Functional endoscopy for hiatal hernia
Region
Japan

Condition
Condition Esophagus achalasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Currently, in patients with GERD symptoms, the degree of reflux and nature are evaluated using a 24-hour pH impedance test (insurance medical examination). This is currently the most useful and objective indicator. However, restraint for 24 hours (hospitalization for one night) is essential, and from the viewpoint of medical economics, if it is possible to conduct alternative tests in a simple manner, it is highly practical. In this research, we aim to contribute greatly to the diagnosis of reflux esophagitis by devising endoscopic examination (addition of SHS examination: see below).
We have reached the following hypothesis from the observation of numerous refractory GERD cases undergoing endoscopic cardia resection (ARMS) (approved by our ethics committee). Among esophageal hiatal hernias, the case where the contractile ability of the LES (lower esophageal sphincter) located at the lower end of the esophagus remains is a finding that the mucous membrane is wrapped around the scope due to contraction of the LES at the time of reversal observation of the endoscope ( Scoped holding sign (SHS)) is often observed. On the other hand, in GERD cases (including NERD cases), the contraction of LES is insufficient (or short time). Focus on this point and evaluate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between the presence of SHS and GERD symptoms
Key secondary outcomes Scope holding position (position where the mucosa winds around the scope), presence or absence of peristaltic wave, duration of the gap

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 1) Showa University Patient undergoing upper gastrointestinal endoscopy in a patient who is visiting Godo Toyosu Hospital digestive organ center.
2) Patients who aged 20 to over 80 years of age at the time of acquisition.
3) Patients who consented to their participation in this study by written consent.
Key exclusion criteria 1) Patients aged 20 years or older, patients aged 80 years or older at the time of acquisition.
2) Patients who take 3 or more doses of anticoagulants / antiplatelets.
3) Patients complaining of active ulcer.
4) Patients who have malignant gastrointestinal disease.
5) Patient judged inappropriate at the discretion of the research doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Haruhiro
Middle name
Last name Inoue
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code 1358577
Address Toyosu 5-1-38, Koto-ku, Tokyo-to
TEL 03-6204-6000
Email picatyu2@yahoo.co.jp

Public contact
Name of contact person
1st name Kazuya
Middle name
Last name Sumi
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code 1358577
Address Toyosu 5-1-38, Koto-ku, Tokyo-to
TEL 03-6204-6000
Homepage URL
Email picatyu2@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)

IRB Contact (For public release)
Organization Showa University Koto-Toyosu Hospital IRB
Address Toyosu 5-1-38, Koto-ku, Tokyo-to
Tel 0362046000
Email th_irb@ofc.showa-u.ac.jp

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 05 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 05 Month 22 Day
Last modified on
2020 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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