UMIN-CTR Clinical Trial

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
Email	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
Email	tsuru-h@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Bioregulatory Science,Graduate school of Medical Sciences,Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049583