UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063589 |
|---|---|
| Receipt number | R000072767 |
| Scientific Title | Registry Study of Esophageal Function Testing and Treatment |
| Date of disclosure of the study information | 2026/11/11 |
| Last modified on | 2026/11/11 10:18:35 |
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Basic information
Public title
Registry Study of Esophageal Function Testing and Treatment
Acronym
Registry Study of Esophageal Function Testing and Treatment
Scientific Title
Registry Study of Esophageal Function Testing and Treatment
Scientific Title:Acronym
Registry Study of Esophageal Function Testing and Treatment
Region
| Japan |
Condition
Condition
Patients with suspected esophageal functional disorders, including esophageal motility disorders and gastroesophageal reflux disease (GERD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the associations between objective parameters obtained from high-resolution esophageal manometry (HRM) and 24-hour esophageal pH-impedance monitoring and patient-reported symptoms, including heartburn, chest pain, dysphagia, and globus sensation. Furthermore, this study prospectively evaluates changes in symptoms and diagnostic findings following pharmacological, endoscopic, and surgical treatments, with the goal of contributing to the development of optimal diagnostic and therapeutic strategies for esophageal functional disorders.
Basic objectives2
Others
Basic objectives -Others
To prospectively evaluate the associations between esophageal function test findings and clinical symptoms, as well as changes in symptoms and test findings following treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Associations of esophageal function test parameters with clinical symptoms and therapeutic interventions.
Key secondary outcomes
Associations among esophageal function test findings, clinical symptoms, endoscopic findings, gastrointestinal radiographic findings, laboratory parameters, and therapeutic interventions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled to undergo high-resolution esophageal manometry (HRM) or 24-hour esophageal pH-impedance monitoring at Keio University Hospital.
2.Patients aged 18 years or older at the time of informed consent.
3.Patients who have received sufficient information about the study and provided written informed consent.
Key exclusion criteria
1.Patients who decline to participate in the study.
2.Patients deemed unsuitable for participation by the treating physician.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
mori-d@keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mori-d@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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
| 2026 | Year | 11 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study conducted at Keio University Hospital. Data on esophageal function testing and treatment performed as part of routine clinical practice will be collected. No study-specific therapeutic interventions or treatment allocation will be performed.
Management information
Registered date
| 2026 | Year | 11 | Month | 11 | Day |
Last modified on
| 2026 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072767
