UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043505 |
|---|---|
| Receipt number | R000049583 |
| Scientific Title | Elucidation of esophageal motility disorders associated with aspiration pneumonia not caused by oral and pharyngeal stages. a prospective observational study. |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2021/03/03 01:32:50 |
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Basic information
Public title
Elucidation of esophageal motility disorders associated with aspiration pneumonia not caused by oral and pharyngeal stages.
a prospective observational study.
Acronym
Elucidation of esophageal motility disorders associated with aspiration pneumonia not caused by oral and pharyngeal stages.
a prospective observational study.
Scientific Title
Elucidation of esophageal motility disorders associated with aspiration pneumonia not caused by oral and pharyngeal stages.
a prospective observational study.
Scientific Title:Acronym
Elucidation of esophageal motility disorders associated with aspiration pneumonia not caused by oral and pharyngeal stages.
a prospective observational study.
Region
| Japan |
Condition
Condition
aspiration pneumonia
esophageal motility disorders
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pathophysiology of aspiration pneumonia caused by subclinical aspiration of gastroesophageal reflux products.
Basic objectives2
Others
Basic objectives -Others
To establish a method for prevention of aspiration pneumonia caused by subclinical aspiration of gastroesophageal reflux products.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the actual status of each esophageal motility disorders involved in aspiration pneumonia not caused by the oral and pharyngeal phases.
Key secondary outcomes
To clarify the pattern of esophageal motility disorders that lead to aspiration pneumonia.
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
Patient Group
1.Patients presumed to have developed aspiration pneumonia caused by esophageal dysphagia.
2.Patients who fully understand this research plan and are able to give informed consent.
3.Patients who are 20 years of age or older at the time of consent.
Control group
Patients with normal results of high-resolution esophageal manometry and 24-hour pH/impedance monitoring (patients with reflux hypersensitivity esophagus or functional heartburn) will be included
1.Patients who fully understand this research plan and are able to give informed consent
2.Patients who are 20 years of age or older at the time of consent
Key exclusion criteria
1.Patients with a poor general condition (PS value of 3 or higher).
2.Patients who are judged by the researcher to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruei |
| Middle name | |
| Last name | Ogino |
Organization
Kyushu University Hospital
Division name
Hepatology & Pancreatology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city 812-8582, Japan
TEL
0926425286
ogino@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Tsuru |
Organization
Graduate school of Medical Sciences,Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city 812-8582, Japan
TEL
0926425286
Homepage URL
tsuru-h@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory Science,Graduate school of Medical Sciences,Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu university
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
Kyushu university,Center for Clinical and Translational Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city 812-8582, Japan
Tel
092-642-5774
ijkseimei@jimu.kyushu-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
| 2021 | Year | 03 | Month | 03 | 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
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study.
Patients with a history of aspiration pneumonia will be referred to us from our department's affiliated facilities that treat aspiration pneumonia, and we will treat them at our university. With the cooperation of the Department of Otorhinolaryngology, Graduate School of Medicine, Kyushu University, we will exclude patients with oral and pharyngeal stage dysfunctions and select patients who are presumed to have developed aspiration pneumonia caused by subclinical aspiration due to esophageal stage dysphagia. In parallel, we will treat patients with a history of aspiration pneumonia who have been consulted to the Department of Otorhinolaryngology, Kyushu University Graduate School of Medicine for the purpose of swallowing function evaluation, and who are suspected to have esophageal stage dysphagia without any abnormalities in oral/pharyngeal stage swallowing function.
To be performed: esophagogastroduodenoscopy, esophageal radiography, high-resolution esophageal manometry, 24-hour pH/impedance test, blood test
Obtain patient information from medical records.
The patients will be compared with a control group without a history of aspiration pneumonia.
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
