UMIN-CTR Clinical Trial

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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