UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015016 |
|---|---|
| Receipt number | R000017467 |
| Scientific Title | Removal of small colorectal polyps from 3 to 6mm in size: a prospective randomized comparative study between cold snare polypectomy and hot biopsy |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/06/15 17:30:56 |
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Basic information
Public title
Removal of small colorectal polyps from 3 to 6mm in size: a prospective randomized comparative study between cold snare polypectomy and hot biopsy
Acronym
A prospective randomized comparative study between CSP and HOT
Scientific Title
Removal of small colorectal polyps from 3 to 6mm in size: a prospective randomized comparative study between cold snare polypectomy and hot biopsy
Scientific Title:Acronym
A prospective randomized comparative study between CSP and HOT
Region
| Japan |
Condition
Condition
Patients who have colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of cold snare polypectomy and hot biopsy in the removal of small colorectal polyps from 3 to 6 mm in size
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Curative resection rate
Evaluation of cut margin
1)Endoscopic evaluation: to confirm a tumor-free cut margin with magnified endoscopic view
2)Pathological evaluation: to confirm a tumor-free cut margin with microscopic view
En bloc resection rate
Key secondary outcomes
Polyp retrieval rate
Immediate bleeding, immediate perforation after polypectomy
Delayed bleeding, delayed perforation after polypectomy
Clipping required forRequired for bleeding or perforation
Local recurrence 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
more than 20 years old
Patients undergoing removal of colorectal polyps of target size
Written informed consent
Key exclusion criteria
Polyps suspected of being cancerous
Patients with inflammatory bowel disease
Hyperplastic polyps less than 5 mm in the distal colorectum
Patient without informed consent
Others who did not agree to cooperate with the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoriaki Komeda |
Organization
Kinki University, School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL
(072)366-0221
y-komme@mvb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoriaki Komeda |
Organization
Kinki University, School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL
(072)366-0221
Homepage URL
y-komme@mvb.biglobe.ne.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Kinki University, School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
