UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054593 |
|---|---|
| Receipt number | R000062381 |
| Scientific Title | Investigation on complications caused by barium/foaming agents after upper gastrointestinal X-ray examination |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/06 16:38:20 |
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Basic information
Public title
Investigation on complications caused by barium/foaming agents after upper gastrointestinal X-ray examination
Acronym
Investigation on complications caused by barium/foaming agents after upper gastrointestinal X-ray examination
Scientific Title
Investigation on complications caused by barium/foaming agents after upper gastrointestinal X-ray examination
Scientific Title:Acronym
Investigation on complications caused by barium/foaming agents after upper gastrointestinal X-ray examination
Region
| Japan |
Condition
Condition
complications caused by barium/foaming agents after upper gastrointestinal X-ray examination
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In upper gastrointestinal X-ray examinations, a foaming agent is taken immediately before the examination to inflate the stomach with carbon dioxide gas, and the examination is performed using a barium contrast agent. Studies conducted by academic societies and other organizations have revealed the occurrence of accidental symptoms caused by the use of foaming agents and barium contrast agents during examinations, but it is not possible to ascertain the occurrence of accidental symptoms and the severity of symptoms that occur after patients return home. Not yet. This time, we planned a study to investigate the occurrence and severity of symptoms one week after the test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regarding incidental events related to upper gastrointestinal X-ray examination, whether or not they have occurred one week after the examination.
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
Those who underwent a complete medical checkup or stomach X-ray examination for gastric cancer screening
Key exclusion criteria
Persons who cannot consent to participate in research
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | TSUNEYA |
| Middle name | |
| Last name | WADA |
Organization
Okazaki Medical Association
Division name
Harusaki Medical Center
Zip code
4440875
Address
1-9-1 Tatsumi-nishi Okazaki Aichi
TEL
0564521572
t-wada@okazaki-med.or.jp
Public contact
Name of contact person
| 1st name | TSUNEYA |
| Middle name | |
| Last name | WADA |
Organization
Okazaki Medical Association
Division name
Harusaki Medical Center
Zip code
4440875
Address
1-9-1 Tatsumi-nishi Okazaki Aichi
TEL
0564521572
Homepage URL
t-wada@okazaki-med.or.jp
Sponsor or person
Institute
Okazaki Medical Association
Institute
Department
Personal name
Funding Source
Organization
Okazaki Medical Association
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
Nagoya City University Hospital
Address
1 Kawasumi Mizuho Nagoya Aichi
Tel
052-858-7215
irb_jimu@med.nagoya-cu.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
| 2024 | Year | 07 | Month | 01 | 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
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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Explanation of research content)
After the gastric X-ray examination is completed, the researcher will explain about participating in the questionnaire survey in the examination room.
(Observation of subjective symptoms and answering questionnaires)
Research subjects were observed after returning home, and the subjects were checked for "5.5.4 Observation and Test Items" such as their physical condition before the test, the number of times they took laxatives after the test, the number of days until barium stool was excreted, and their subjective symptoms up to one week later. After answering the questionnaire regarding the contents, mail it to the research office using a return envelope.
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062381
