UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028764 |
|---|---|
| Receipt number | R000032918 |
| Scientific Title | Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment. |
| Date of disclosure of the study information | 2017/08/22 |
| Last modified on | 2017/08/21 19:57:17 |
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Basic information
Public title
Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Acronym
Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Scientific Title
Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Scientific Title:Acronym
Comparative risk of gastrointestinal bleeding in patients with anticoagulants undergoing endoscopic treatment.
Region
| Japan |
Condition
Condition
early esophageal cancer/early gastric cancer/early colon cancer/gastric adenoma/colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify as to wether endoscopic treatment with anticoagulants increase the risk of complications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the frequency of bleeding after treatment of endoscopy.
Key secondary outcomes
adverse event rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The safety of anticoaglants
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who take anticoagulation.
Key exclusion criteria
Patients ineligible for this study.
Patients administer treatment of hepalinization.
Without the consent of the patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine.
Division name
Gastroenterology
Zip code
Address
1-1 Mucogawa cho Nishinomiya city Hyogo
TEL
0798-45-6662
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kitayama |
Organization
Hyogo College of Medicine.
Division name
Gastroenterology
Zip code
Address
1-1 Mucogawa cho Nishinomiya city Hyogo
TEL
0798-45-6662
Homepage URL
yoshitaka591027@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine.
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 08 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032918
| 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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