UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046411 |
|---|---|
| Receipt number | R000052955 |
| Scientific Title | The clinical factors of acute abdominal symptom induced by gastric anisakiasis |
| Date of disclosure of the study information | 2021/12/22 |
| Last modified on | 2023/09/24 12:38:06 |
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Basic information
Public title
The clinical factors of acute abdominal symptom induced by gastric anisakiasis
Acronym
The clinical factors of acute abdominal symptom induced by gastric anisakiasis
Scientific Title
The clinical factors of acute abdominal symptom induced by gastric anisakiasis
Scientific Title:Acronym
The clinical factors of acute abdominal symptom induced by gastric anisakiasis
Region
| Japan |
Condition
Condition
gastric anisakiasis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze cases diagnosed with gastric anisakiasis and to examine clinical factors involved in the appearance of symptoms.
Basic objectives2
Others
Basic objectives -Others
Clinical factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyzing clinical factors in symptomatic and asymptomatic cases of gastric anisakiasis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with gastric anisakiasis by upper gastrointestinal endoscopy
Key exclusion criteria
(1) Patients whose background gastric mucosa cannot be evaluated.
(2) Patients who have stated refusal to use clinical data.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Sumiyoshi |
Organization
Tonan Hospital
Division name
Gastroenterology
Zip code
060-0004
Address
North 4, West 7, chuo-ku, Sapporo, Hokkaido, Japan
TEL
0112312121
t-sumiyoshi@tonan.gr.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Tomita |
Organization
Tonan Hospital
Division name
Gastroenterology
Zip code
060-0004
Address
North 4, West 7, chuo-ku, Sapporo, Hokkaido, Japan
TEL
0112312121
Homepage URL
yusuke.tomita@tonan.gr.jp
Sponsor or person
Institute
Tonan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Tonan Hospital
Address
North 4, West 7, chuo-ku, Sapporo, Hokkaido, Japan
Tel
0112312121
tonanhsp@tonan.gr.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 | 12 | Month | 22 | 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
264
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052955
