UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018200 |
|---|---|
| Receipt number | R000019920 |
| Scientific Title | A randomised contorl study comparing the safety of cold snare polypectomy in patients with colorectal polyp below 10 mm at high versus low risk of bleeding |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2019/02/17 13:18:26 |
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Basic information
Public title
A randomised contorl study comparing the safety of cold snare polypectomy in patients with colorectal polyp below 10 mm at high versus low risk of bleeding
Acronym
A study comparing the safety of CSP on warfarin v.s. warfarin plus antiplatelet agents
Scientific Title
A randomised contorl study comparing the safety of cold snare polypectomy in patients with colorectal polyp below 10 mm at high versus low risk of bleeding
Scientific Title:Acronym
A study comparing the safety of CSP on warfarin v.s. warfarin plus antiplatelet agents
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of cold snare polypectomy for colorectal polyp below 10mm in a randomized controlled trial comparing warfarin alone with adding warfarin to antiplatelet agents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Delayed bleeding rate
Key secondary outcomes
Procedural bleeding control rate
Procedure related adverse events
Rate of residual tumor
Incidence of perioperative arterial or venous thromboembolism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Medicine | Maneuver |
Interventions/Control_1
Cold snare polypectomy on warfarin
Interventions/Control_2
Cold snare polypectomy on warfarin and antiplatelet agents
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)20 y.o. or older
2)Patients with colorectal polyps <= 10mm
3)Patients who gave written informed consent
4)Patients who continued warfarin
5)Patients who continued both warfarin and antiplatelet agent
Key exclusion criteria
1)polyps >10mm
2)Patients with severe comorbidity
3)Patients during pregnancy
4)bleeding tendency except for a drug
5)others
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Harada |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology and Clinical Research Institute
Zip code
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
haradan@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yorinobu Sumida |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Gastroenterology and Clinical Research Institute
Zip code
Address
1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
yorinobu@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | 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
| 2015 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019920
| 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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| Registered date | File name |
