UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015913 |
|---|---|
| Receipt number | R000018520 |
| Scientific Title | A randomized trial of evaluation for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps |
| Date of disclosure of the study information | 2014/12/11 |
| Last modified on | 2016/06/22 21:51:09 |
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Basic information
Public title
A randomized trial of evaluation for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps
Acronym
A randomized trial of evaluation for the usefulness of cold polypectomy
Scientific Title
A randomized trial of evaluation for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps
Scientific Title:Acronym
A randomized trial of evaluation for the usefulness of cold polypectomy
Region
| Japan |
Condition
Condition
Colorectal polyp(<10mm)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of
cold polypectomy for minute colorectal polyps(<10mm)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Delayed bleeding rate(within 2 weeks after polypectomy)
Key secondary outcomes
Delayed bleeding rate in patients with anticoagulant therapy and antiplatelet therapy/complete resection rate/recurrence rate after one year/immediate bleeding rate required hemostatic clipping/pathological investigation (complete resection rate ,vertical range of 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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cold polypectomy
Interventions/Control_2
conventional polypectomy
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 with non-pedunculated colorectal polyp <10 mm
2)Written informed consent
Key exclusion criteria
1)polyps >10mm
2)previous chemotherapy and radiotherapy for colorectal cancer
3)others
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65,Tsurumai-cho,Shouwa-ku,Nagoya
TEL
052-744-2164
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamura |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65,Tsurumai-cho,Shouwa-ku,Nagoya
TEL
052-741-2172
Homepage URL
tyamamu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Nagoya 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
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 11 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2014 | Year | 12 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
