UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014812 |
|---|---|
| Receipt number | R000017222 |
| Scientific Title | Safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma (<10mm) : a prospective cohort study. |
| Date of disclosure of the study information | 2014/08/11 |
| Last modified on | 2016/11/12 16:34:53 |
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Basic information
Public title
Safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma (<10mm) : a prospective cohort study.
Acronym
A prospective cohort study of Cold polypectomy
Scientific Title
Safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma (<10mm) : a prospective cohort study.
Scientific Title:Acronym
A prospective cohort study of Cold polypectomy
Region
| Japan |
Condition
Condition
Colorectal adenoma <10mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma <10mm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Delayed bleeding
Key secondary outcomes
Immediate bleeding, Perforation, Procedure time, Endoscopical en bloc resection rate, Rate of advanced neoplasia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cold polypectomy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Endoscopically diagnosed as colorectal adenoma <10mm
2)20 y.o< and 80 y.o>
3)Outpatient(Day surgery)
4)Written informed consent
Key exclusion criteria
1)20 y.o> or 80 y.o<
2)Pregnant
3)Pedunculated lesion
4)Patients with IBD, familial adenomatous polyposis
5)Patients with important organ failure
6)Patients with anticoagulant therapy, clopidogrel, ticlopidine, thrombin inhibitor, combination therapy of antiplatelet agents.
7)Poor bowel preparation
8)Patients undergoing polypectomy for colorectal polyp(>10mm)
9)Others
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Shimodate |
Organization
Kurashiki Central Hospital
Division name
Department of gastroenterology
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
ys13544@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Shimodate |
Organization
Kurashiki Central Hospital
Division name
Department of gastroenterology
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ys13544@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central 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
None
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
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017222
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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