UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021518 |
|---|---|
| Receipt number | R000024817 |
| Scientific Title | A comparison study of cold snare polypectomy and EMR for patients taking warfarin. |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2020/03/23 16:43:16 |
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Basic information
Public title
A comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Acronym
Comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Scientific Title
A comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Scientific Title:Acronym
Comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safeness of cold snare polypectomy for colorectal polyps in patients taking warfarin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delayed bleeding(within 2 weeks after procedure)
Key secondary outcomes
Immediate bleeding, adverse events other than bleeding, rate of complete resection.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
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 warfarin.
Interventions/Control_2
To perform EMR 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients taking warfarin.
2. Patients who had colorectal polyps <10 mm,not suspected of early cancer,and not pedunculated .
Key exclusion criteria
1.Inflammatory bowel diseases
2. family polyposis
3.Hb< 9 g/dl
4.PT-INR>= 3
5.Pregnant women
6.Patients who undergo artificial dialysis
7.patients taking other anticoagulants
8.others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Morita |
Organization
Kobe University Hospital
Division name
Depertment of gastroenterology
Zip code
6500017
Address
7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL
078-382-5111
ymorita@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Wakahara |
Organization
Kobe University Hospital
Division name
Depertment of gastroenterology
Zip code
6500017
Address
7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL
078-382-5111
Homepage URL
wakahara@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kobe
Address
Kobe
Tel
0783825652
rinri@med.kobe-u.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
神戸大学医学部附属病院および関連病院群
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024817
