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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016824
Receipt No. R000019530
Scientific Title Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp
Date of disclosure of the study information 2015/03/17
Last modified on 2018/03/18

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Basic information
Public title Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp
Acronym Local recurrence after cold polypectomy for colorectal polyp
Scientific Title Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp
Scientific Title:Acronym Local recurrence after cold polypectomy for colorectal polyp
Region
Japan

Condition
Condition Colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the rate of pathological local recurrence after cold snare polypectomy (CSP) for colorectal polyp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of pathological local recurrence at 3 weeks after CSP for colorectal polyp
Key secondary outcomes The rate of morphological local recurrence at 3 weeks after CSP for colorectal polyp

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent CSP for colorectal polyps
Key exclusion criteria Patients with severe renal failure or heart failure, or evaluated incompetent by doctors in attendance
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Maruoka
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL 043-226-2083
Homepage URL
Email maruoka-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
Email

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 千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29415287
Number of participants that the trial has enrolled
Results 
Overall, 126 lesions in 39 patients were removed and 125 (99.2？%) were resected en bloc using CSP. Pathologically, 111 lesions (88.1？%) were confirmed as adenomas (4.2 +- 1.5？mm), with 36 of these (32.4？%) determined to be R0 resections. No complications were observed. All 37 patients with pathologically confirmed adenomas underwent follow-up colonoscopy, and 102 of 111 scars were detected in 33 patients. One pathological residual adenoma (0.98？%, 95？% confidence interval 0.02？%？-？5.3？%) was identified.
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 01 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 02 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 Safety and efficacy of UCSP for colorectal polyps will be analyzed.

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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