UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019595 |
|---|---|
| Receipt number | R000022654 |
| Scientific Title | Safety of colonoscopic therapy under continuance of warfarin |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2021/09/26 22:28:44 |
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Basic information
Public title
Safety of colonoscopic therapy under continuance of warfarin
Acronym
Safety of colonoscopic therapy with warfarin
Scientific Title
Safety of colonoscopic therapy under continuance of warfarin
Scientific Title:Acronym
Safety of colonoscopic therapy with warfarin
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postoperative hemorrhage of colonoscopic therapy with warfarin are analyzed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative hemorrhage until 4 months after intervention.
Key secondary outcomes
The rate of moderate-severe perioperative hemorrhage
The rate of thromboembolism
The change of PT-INR
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic threpy of colorectal polyps for patients with warfarin
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with warfarin for thromboembolism
Key exclusion criteria
Cases with main organ dysfunction
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
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
京都府立医科大学附属病院(京都府)、京都府立北部医療センター(京都府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 01 | Day |
Other
Other related information
Patients recieving warfarin, who will receive colonoscopic surgery for colorectal polyps are recruited for this study. Main measurements of this study is therapeutic results including postoperative hemorrahge.
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022654
