UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013520 |
|---|---|
| Receipt number | R000015790 |
| Scientific Title | Study of upper gastrointestinal endoscopic biopsies risk in patient on antithrombotic therapy |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2015/03/26 14:25:09 |
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Basic information
Public title
Study of upper gastrointestinal endoscopic biopsies risk in patient on antithrombotic therapy
Acronym
Study of upper gastrointestinal endoscopic biopsies risk in patient on antithrombotic therapy
Scientific Title
Study of upper gastrointestinal endoscopic biopsies risk in patient on antithrombotic therapy
Scientific Title:Acronym
Study of upper gastrointestinal endoscopic biopsies risk in patient on antithrombotic therapy
Region
| Japan |
Condition
Condition
Lesions that performed upper gastrointestinal endoscopic biopsy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the bleeding risk of upper gastrointestinal endoscopic biopsy in antithrombotic agent under continuation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The bleeding risk of upper gastrointestinal endoscopic biopsy in antithrombotic agent under continuation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are performed gastrointestinal endoscopic biopsy under anti-thrombotic agents administration.
For comparison, patients who are matdhed sex and age(within 5 years up and down) , without management of anti-thrombotic drugs are performed gastrointestinal endoscopic biopsy.
Key exclusion criteria
Emergency endoscopy cases.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Yuki |
Organization
Shimane University Hospital
Division name
Division of Gastrointestinal Endoscopy
Zip code
Address
89-1, Enya-cho, Izumo, Shimane,
TEL
0853-20-2190
yukitaka@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Yuki |
Organization
Shimane University Hospital
Division name
Division of Gastrointestinal Endoscopy
Zip code
Address
89-1, Enya-cho, Izumo, Shimane,
TEL
0853-20-2190
Homepage URL
yukitaka@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | 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
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
| 2012 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the situation in the date of registration and after 30 days.
Management information
Registered date
| 2014 | Year | 03 | Month | 26 | Day |
Last modified on
| 2015 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015790
| 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 |
