UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027448 |
|---|---|
| Receipt number | R000028169 |
| Scientific Title | Functional endoscopy for hiatal hernia |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2023/11/09 09:16:28 |
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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
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
picatyu2@yahoo.co.jp
Sponsor or person
Institute
Showa University Koto-Toyosu Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
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
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028169
