UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011114 |
|---|---|
| Receipt number | R000013021 |
| Scientific Title | Survey of the endoscopic diagnostic capability on eosinophilic esophagitis |
| Date of disclosure of the study information | 2013/07/04 |
| Last modified on | 2015/01/19 11:43:22 |
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Basic information
Public title
Survey of the endoscopic diagnostic capability on eosinophilic esophagitis
Acronym
Survey of the endoscopic diagnostic capability on eosinophilic esophagitis
Scientific Title
Survey of the endoscopic diagnostic capability on eosinophilic esophagitis
Scientific Title:Acronym
Survey of the endoscopic diagnostic capability on eosinophilic esophagitis
Region
| Japan |
Condition
Condition
eosinophilic esophagitis (EoE)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic findings such as longitudinal linear furrows, multiple concentric ring and whitish exudates might indicate the presence of EoE. We aimed to determine the sencitivity, specificity and diagnostic utility of endoscopic features of EoE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eosinophilis infiltration of esophageal epithelium (EoE is diagnosed with 15 eosinophilis/ highpowered field (HPF))
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We targeted outpatients who had been examined with endoscopy for chest and epigastric symptoms.
Key exclusion criteria
Patients taking glucocorticoid over 2 months and having high risk of bleeding for biopsy were excluded.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
0853-20-2190
shimurashino@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
0852-23-2190
Homepage URL
shimurashino@yahoo.co.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
島根大学医学部（島根県）、島根県立中央病院（島根県）、松江赤十字病院（島根県）、松江市立病院（島根県）、松江生協病院（島根県）、松江記念病院（島根県）、出雲市立総合医療センター（島根県）、出雲市民病院（島根県）、玉造厚生年金病院（島根県）、雲南市立病院（島根県）、大田市立病院（島根県）、町立奥出雲病院（島根県）、益田地域医療センター医師会病院（島根県）、加藤病院（島根県）、鳥取生協病院（鳥取県）、鳥取市立病院（鳥取県）、市立加西病院（兵庫県）、倉敷成人病センター（岡山県）、姫路愛和病院（兵庫県）、森医院（島根県）、吉田医院（島根県）、乃木クリニック（島根県）、合原病院（島根県）、門脇内科胃腸科医院（島根県）、三原医院（島根県）、山根病院（島根県）、たまゆ内科クリニック（島根県）、津田小学校前よしの医院（島根県）、泉胃腸科医院（島根県）、はしもと内科クリニック（島根県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 319 patients with abdominal symptoms, 8 (2.5%) had EE, and 3 (0.9%)were finally diagnosed with EoE. The most useful endoscopic findings for diagnosis of EE was linear furrows, whereas subjective symptoms were not supportive.
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
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2015 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013021
| Research Plan | |
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| 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 |
