UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003750 |
|---|---|
| Receipt number | R000004535 |
| Scientific Title | The safety evaluation of endoscopic biopsy against patients receiving anticoagulatns and antiplatelet agents. |
| Date of disclosure of the study information | 2010/06/16 |
| Last modified on | 2012/06/14 09:05:09 |
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Basic information
Public title
The safety evaluation of endoscopic biopsy against patients receiving anticoagulatns and antiplatelet agents.
Acronym
The safety evaluation of endoscopic biopsy during antithrombotic therapy.
Scientific Title
The safety evaluation of endoscopic biopsy against patients receiving anticoagulatns and antiplatelet agents.
Scientific Title:Acronym
The safety evaluation of endoscopic biopsy during antithrombotic therapy.
Region
| Japan |
Condition
Condition
Outpatients undergoing gastrointestinal endoscopy during antithrombotic therapy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to evaluate safety of endoscopic biopsy in gastrointestinal tract for patients receiving anticoagulatns and antiplatelet agents without cessation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal bleeding during two weeks after biopsy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic biopsy
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
(A)Medical need of gastrointestinal endoscopy.
(B)Comorbidity requiring antithrombotic therapy.
(C)Receiving anticoagulants and/or antiplatelet agents.
(D)Informed consent.
(E)Performance status(ECOG):0-2.
(F)Scheduled blood test about two weeks after biopsy.
(G)Outpatient.
Key exclusion criteria
(A)Strong possibility of lesions requiring more invasive procedures than biopsy.
(B)During hospitalization.
(C)Other severe comorbidities.
(D)During anticancer chemotherapy.
(E)Severe hematological, hepatological, or renal disorder accompanied with hemorrhagic tendency.
(F)INR exceeding the upper limit shown in the guideline by Japanese circulation society.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
Graduate School of Medicine, The University of Tokyo.
Division name
Department of Endoscopy and Endoscopic Surgery.
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
Graduate School of Medicine, The University of Tokyo.
Division name
Department of Gastroenterology.
Zip code
Address
TEL
Homepage URL
satoshi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo.
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo.
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22350697
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
| 2010 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 14 | Day |
Last modified on
| 2012 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004535
