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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013520
Receipt No. 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

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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
Email 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
Email yukitaka@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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