UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038655 |
|---|---|
| Receipt number | R000044053 |
| Scientific Title | Evaluation of EUS findings for the detection of esophageal motility disorders |
| Date of disclosure of the study information | 2019/11/21 |
| Last modified on | 2023/11/24 18:33:12 |
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Basic information
Public title
Evaluation of EUS findings for the detection of esophageal motility disorders
Acronym
Evaluation of EUS findings for the detection of esophageal motility disorders
Scientific Title
Evaluation of EUS findings for the detection of esophageal motility disorders
Scientific Title:Acronym
Evaluation of EUS findings for the detection of esophageal motility disorders
Region
| Japan |
Condition
Condition
Esophageal achalasia (subtypeI, II, III)
Esophagogastric junction outflow obstruction
Distal esophageal spasm
Jackhammer esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether it is possible to detect and diagnose esophageal motility disorders by the measurement of the esophageal wall thickness in EUS.
Basic objectives2
Others
Basic objectives -Others
Utility of EUS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between each esophageal motility disorders and the thickness of the esophageal wall and muscle in EUS
Key secondary outcomes
Thickness change of the esophageal wall and muscle after therapy in each esophageal motility disorders
The correlation between each esophageal motility disorders and the following items; age, sex, body height and weight, symptom, disease duration, pretherapy, esophageal high-resolution manometry, barium test, endoscopy
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
1. Patients with esophageal motility disorders.
2. Patients where written informed consent is obtained.
3. Patients older than 20 years old.
Key exclusion criteria
1. Patients who has underwent endoscopic or surgical esophageal myotomy.
2. Patients who are judged as being inappropriate for this study by their medical doctors.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Eikichi |
| Middle name | |
| Last name | Ihara |
Organization
Graduate school of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan
TEL
0926425286
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Hata |
Organization
Graduate school of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan
TEL
0926425286
Homepage URL
yo-hata@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory, 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
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425082
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
| 2019 | Year | 11 | Month | 21 | 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
33
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
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 21 | 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
Observational study
Management information
Registered date
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044053
