UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044797 |
|---|---|
| Receipt number | R000051162 |
| Scientific Title | Usefulness of onigiri esophagography for esophageal motility disorders screening: a multicenter, prospective study |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2024/02/28 19:22:04 |
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Basic information
Public title
Usefulness of onigiri esophagography for esophageal motility disorders screening: a multicenter, prospective study
Acronym
Usefulness of onigiri esophagography for EMD screening: a multicenter, prospective study
Scientific Title
Usefulness of onigiri esophagography for esophageal motility disorders screening: a multicenter, prospective study
Scientific Title:Acronym
Usefulness of onigiri esophagography for EMD screening: a multicenter, prospective study
Region
| Japan |
Condition
Condition
Esophageal motility disorders(EMD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of onigiri esophagography for esophageal motility disorders screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in sensitivity of EMD screening by onigiri esophagography compared with conventional barium esophagography
Key secondary outcomes
-Sensitivity and specificity of onigiri esophagography for EMD screening
-Interobserver agreement rate of onigiri esophagography
-Diagnostic ability of onigiri esophagography using obstruction level (ROC analysis)
-Diagnostic ability of onigiri esophagography for each EMD
-Correlation between symptom scores and onigiri esophagography
-Multivariate analysis of factors related to diagnostic ability
-Increased diagnostic ability for EMD by the findings including wave appearance and weak peristalsis
-Diagnostic ability for EMD by the length of dispersed onigiri in the esophagus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Onigiri esophagography
The addition of onigiri esophagography to conventional barium esophagography requires an additional examination time of about 2 minutes and a radiation exposure of about 20 mGy.
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
1.Patients with symptoms suspected of esophageal motility disorders, such as a dysphagia, chest pain, regurgitation.
2.Patients with no structural abnormalities on upper gastrointestinal endoscopy
3.Patients who are 20 years old or older at the time of obtaining consent
4.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of each eligible patient is 0, 1, or 2.
5.Patients who can understand the explanation of this research plan and can give their own consent.
Key exclusion criteria
1.Pregnant women or patients who may be pregnant
2.Patients with a history of esophageal or esophagogastric junction surgery
3.Patients at high risk of aspiration from liquid and solid swallowing
4.Patients with a history of intestinal obstruction
5.Patients with allergy to barium test
6.Patients who are judged inappropriate by physician participating in this trial
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Haruei |
| Middle name | |
| Last name | Ogino |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5286
ogino.haruei.600@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Wada |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
0926425286
Homepage URL
wada.masafumi.710@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kyushu 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
Kyushu University Institutional Review Board for Clinical Trials
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@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 | 07 | Month | 12 | 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
| Delay expected |
Results Delay Reason
Patient enrollment was completed, but data analysis required more time.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051162
| 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 |
