UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012520 |
|---|---|
| Receipt number | R000014447 |
| Scientific Title | Radomized controled trial that examines effectiveness of cold snare polypectomy for colon polyps less than 10 mm |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2020/08/10 07:05:03 |
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Basic information
Public title
Radomized controled trial that examines effectiveness of cold snare polypectomy for colon polyps less than 10 mm
Acronym
CSP Study
Scientific Title
Radomized controled trial that examines effectiveness of cold snare polypectomy for colon polyps less than 10 mm
Scientific Title:Acronym
CSP Study
Region
| Japan |
Condition
Condition
Patients who have colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare late bleeding rates between cold and hot snare polypectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
late bleeding rate after polypectomy
Key secondary outcomes
early bleeding rate; immediate bleeding rate; bleeding rates by colonoscopy experience, polyp configuration, polyp size and polyp location; negative cut end rate; specimen retrieval rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cold snare polypectomy
Interventions/Control_2
hot snare 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are required to receive polypectomy
Key exclusion criteria
Inflammatory bowel disease
Familial adenomatous polyposis
Poor condition
Impossible to stop anticoagulation therapy
Co-existence of advanced cancer
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Coloproctology
Zip code
969-3492
Address
Aizuwakamatsu-city
TEL
0242-75-2100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Aizawa |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Coloproctology
Zip code
969-3492
Address
Aizuwakamatsu-city
TEL
0242-75-2100
Homepage URL
aizawa-m@fmu.ac.jp
Sponsor or person
Institute
Department of Coloproctology, Aizu Medical Center, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Aizu Medical Center, Fukushima Medical University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hibarigaoka, Fukushima-city, Fukushima
Tel
024-547-1111
rinri@fmu.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
自治医科大学光学医療センター(栃木県）、公立藤田総合病院（福島県）、総合会津中央病院（福島県）、会津西病院（福島県）、福島労災病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
DOI: 10.1055/a-0854-3561
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1055/a-0854-3561
Number of participants that the trial has enrolled
277
Results
Per-patient analyses showed that rates of delayed bleeding in the CSP group of 0.7% (1/142) and 1.48% (2/135) in the HSP group (p=0.53). Per=polyp analyses showed similar results (CSP: 0.83%, 3/361 vs. HSP: 0.83%, 3/361; p=0.32). The mean size of polyps with delayed bleeding was relatively large in the CSP group (9mm) but smaller in the HSP group (2 of 3 were diminutive: 3 and 4 mm). The rate of immediate bleeding was significantly higher in the CSP group vs. HSP group (54% vs.14%, p<0.0001),
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
DOI: 10.1055/a-0854-3561
Participant flow
DOI: 10.1055/a-0854-3561
Adverse events
DOI: 10.1055/a-0854-3561
Outcome measures
DOI: 10.1055/a-0854-3561
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 17 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Presented at DDW2017
Management information
Registered date
| 2013 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014447
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/11/17 | 研究計画書（別紙様式１）許諾版改定20160430.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/11/17 | FixedDataCSP.xlsx |
