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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009109
Receipt No. R000010682
Scientific Title GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Date of disclosure of the study information 2012/10/15
Last modified on 2018/08/31

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Basic information
Public title GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Acronym Osaka GI-anticoagulant (GIANT) study
Scientific Title GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Scientific Title:Acronym Osaka GI-anticoagulant (GIANT) study
Region
Japan

Condition
Condition Patients who are treated with anticoagulant drugs requiring endoscopic biopsy or therapeutics
Classification by specialty
Medicine in general Gastroenterology Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the prevalence of GI bleeding after endoscopy or treatents in patients treated with anticoagulants.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of GI bleeding within one month after the endoscopy or endoscopic treatment
Key secondary outcomes 1. Duration of hospitalization
2. Prevalence of cardiovascular and cerebro- and systemic vascular events after endoscopy or endoscopic treatment
3. Frequency of requiring re-endoscopy
4. Frequency of massive GI bleeding
5. Frequency of massive GI bleeding threatening life
6. Frequency of cerebrovascular 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 taking warfarin or other antigocoagulant drugs (e.g., dabigatran).
2) Patients older than 20 years old.
3) Patients requiring endoscopic biopsy or treatment
4) Patients who gave written informed concent.
Key exclusion criteria 1) Patients with unstable vital sign with high risk of endoscopy.
2) Patients with apparent GI bleeding before endoscopy.
3)Pregnant, breast-feeding women and possibility of pregnancy
4)Patients who will perform endoscopic biopsy and treatment during the same hospitalization period
5)Patients who were considered not suitable to be included in this study by the physician.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Iijima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3621
Homepage URL
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
2012 Year 10 Month 15 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
Results
DOAC administration showed similar post-procedural GI bleeding risk to VKA administration in patients undergoing endoscopic procedures, but it shortened the hospital stay.   
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 09 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 27 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 19 Day
Date trial data considered complete
2016 Year 06 Month 19 Day
Date analysis concluded
2018 Year 03 Month 01 Day

Other
Other related information Patients taking anticoagulants and requiring endoscopic biopsy or treatment will be prospectively registered and will be assessed for the risk of GI bleeding and cerebrovascular events.

Management information
Registered date
2012 Year 10 Month 13 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010682

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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