UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020106 |
|---|---|
| Receipt number | R000023223 |
| Scientific Title | usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2020/12/15 05:26:28 |
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Basic information
Public title
usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Acronym
usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Scientific Title
usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Scientific Title:Acronym
usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness and safeness of cold snare polypectomy for colorectal polyps in patients who are prescribed NOAC or warfarin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
late bleeding(within 2 weeks after procedure)
Key secondary outcomes
early bleeding; adverse events other than bleeding; rate of complete resection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To perform cold snare polypectomy for colorectal polyps in patients taking NOAC.
Interventions/Control_2
To perform cold snare polypectomy for colorectal polyps in patients taking warfarin.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.patients with colorectal polyps who are going to receive endoscopic resection.
2.the polyp is no larger than 10mm, not suspected of high grade or early cancer, and not Ip in morphology.
3.patietns who are taking NOAC or warfarin.
4.NOAC includes dabigatran, rivaroxaban , apixaban, and edoxaban.
Key exclusion criteria
1.combination use of antiplatelet agents.
2.history of inflammatory bowel disease.
3.Patients with severe heart failure, renal failure, psychiatric disorder, liver failure.
4.pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
takma_h@yokohama-cul.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatorogy
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
045-787-2640
umezawa-ykh@umin.ac.jp
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | 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
90
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delay of analysis
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023223
