UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018328 |
|---|---|
| Receipt number | R000021212 |
| Scientific Title | Complete resection rate of cold snare polypectomy: a randomized controlled trial |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/10/15 12:15:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Complete resection rate of cold snare polypectomy: a randomized controlled trial
Acronym
Complete resection rate of cold snare polypectomy: a randomized controlled trial (CRESCENT study)
Scientific Title
Complete resection rate of cold snare polypectomy: a randomized controlled trial
Scientific Title:Acronym
Complete resection rate of cold snare polypectomy: a randomized controlled trial (CRESCENT study)
Region
| Japan |
Condition
Condition
colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps <10 mm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Complete resection rate of polypectomy
Key secondary outcomes
Rate of post-polypectomy bleeding
Polyp retrieval rate
Number of times of additional snaring
Ratio of difficult case to remove polyps by cold snare polypectomy
Procedure time
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 considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cold snare polypectomy
Interventions/Control_2
Hot snare polypectomy (Endoscopic mucosal resection)
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
Patients who had colorectal adenomatous polyps <10 mm.
Key exclusion criteria
Inflammatory bowel diseases
Familial polyposis
Patients who take anticoagulants
Pregnant women
Patients who undergo artificial dialysis
Patients who are classified >ASA classIII
Others
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KAWAMURA Takuji |
Organization
Kyoto Second Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
Address
355-5, Haruobi-cho, Kamigyo-ku, Kyoto, JAPAN
TEL
075-231-5171
kawamurat@kyoto2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KAWAMURA Takuji |
Organization
Kyoto Second Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
Address
355-5, Haruobi-cho, Kamigyo-ku, Kyoto, JAPAN
TEL
075-231-5171
Homepage URL
kawamurat@kyoto2.jrc.or.jp
Sponsor or person
Institute
Kyoto Second Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Endoscopic Device Selection Study Group
Investigator Sponsored Research Program of Boston Scientific
Organization
Division
Category of Funding Organization
Other
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
大阪医科大学 (大阪府）
大阪府立成人病センター （大阪府）
関西医科大学 （大阪府）
北野病院 （大阪府）
京都第二赤十字病院 （京都府）
近畿大学 （大阪府）
神戸大学 （兵庫県）
佐野病院 （兵庫県）
滋賀医科大学 （滋賀県）
市立豊中病院 （大阪府）
多根総合病院 （大阪府）
奈良県立医科大学 （奈良県）
日本赤十字社和歌山医療センター （和歌山県）
ベルランド総合病院 （大阪府）
淀川キリスト教病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://gut.bmj.com/content/early/2017/09/28/gutjnl-2017-314215
Number of participants that the trial has enrolled
Results
The complete resection rate for CSP is not inferior to that for HSP. CSP can be one of the standard techniques for 4-9？mm colorectal polyps.
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
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 09 | Month | 26 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 15 | Day |
Last modified on
| 2017 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021212
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
