UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012066 |
|---|---|
| Receipt number | R000014106 |
| Scientific Title | The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users |
| Date of disclosure of the study information | 2013/10/18 |
| Last modified on | 2020/11/12 08:38:59 |
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Basic information
Public title
The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users
Acronym
O-GUTS clinical study of antithrombotic drugs
Scientific Title
The observational study of the safety assesment during the periendoscopic period in antithrombotic drug-users
Scientific Title:Acronym
O-GUTS clinical study of antithrombotic drugs
Region
| Japan |
Condition
Condition
The case of endoscopic forceps biopsy or endoscopic treatment in patients taking antithrombotic drugs
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the guideline for endoscopic procedures in antithrombotic drug-users from Japan Gastroenterological Endoscopy Society on July 2012
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of bleeding after endoscopic forceps biopsy or endoscopic treatment
Key secondary outcomes
1)The incidence of thromboembolic events
2)The incidence of complications except for bleeding
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
1)Patients who were given a written informed consent
2)Patients who take antithrombotic drugs and need endoscopic forceps biopsy or endoscopic treatment
Key exclusion criteria
Patients who were disqualified for the study by their physiciens
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
Address
2-5-1, 2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyasu Kono, Minoru Matsubara |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL
086-235-7219
Homepage URL
hxnwq178@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observance rate of the guideline
Management information
Registered date
| 2013 | Year | 10 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014106
