UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016143 |
|---|---|
| Receipt number | R000018740 |
| Scientific Title | Evaluation of EGJ (esophagogastric junction) function using elastography |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2019/01/10 21:46:25 |
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Basic information
Public title
Evaluation of EGJ (esophagogastric junction) function using elastography
Acronym
Evaluation of EGJ (esophagogastric junction) function using elastography
Scientific Title
Evaluation of EGJ (esophagogastric junction) function using elastography
Scientific Title:Acronym
Evaluation of EGJ (esophagogastric junction) function using elastography
Region
| Japan |
Condition
Condition
Gastroesophageal Reflux Disease,functional dyspepsia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the possibility of esophageal function evaluation by abdominal ultrasonography (US). To examine the usefulness of US in esophageal function evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To reveal the potential evaluation of organic and functional disorders of the esophagogastric junction by abdominal ultrasound elastography
Key secondary outcomes
To verify whether can be evaluated by abdominal ultrasound elastography a therapeutic effect in post-treatment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Case performed upper gastrointestinal endoscopy and abdominal ultrasonography
Performance Status 0-2
Key exclusion criteria
Case can't keeping in supine state
Case having severe complications or severe mental disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suhara Hiroki |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2602
Homepage URL
h-suhara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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
Address
Tel
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The number of CS as determined by US-EG in 30s was significantly lower in the RE group as compared with the non-RE group 6.0(5.5-6.7) vs 8.6 (6.6-10.0) p>0.00001.
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 20 | Day |
Other
Other related information
The esophagogastric junction using elastography based subcutaneous fat and liver consider the dfference and the ratio in hardness. Change of hardness in each diseases records shape, space and frequency of the waveform prospectively.
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018740
| 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 |
