UMIN-CTR Clinical Trial

Basic information
Public title	Histological evaluation of Mucosal Defect after Cold Snare Polypectomy
Acronym	cold biopsy study
Scientific Title	Histological evaluation of Mucosal Defect after Cold Snare Polypectomy
Scientific Title:Acronym	cold biopsy study
Region	Japan

Condition
Condition	colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine if mucosal layer is completely resected by cold snare polypectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incomplete resection rate of mucosal layer by cold snare polypectomy
Key secondary outcomes

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
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Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	non-pedunculated colorectal polyps with a diameter of 4-9 mm
Key exclusion criteria	Inflammatory bowel disease Polyposis Antiplatelet or anticoaglant can not be stopped Coagulopathy Severe organ failure
Target sample size	221

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoji Takeuchi
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Email	takeuti-yo@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Middle name Last name Satoki Shichijo
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Homepage URL
Email	sitijyo-sa@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2017 Year 07 Month 31 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	Preinitiation
Date of protocol fixation	2017 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 31 Day
Last follow-up date	2018 Year 11 Month 18 Day
Date of closure to data entry	2018 Year 11 Month 18 Day
Date trial data considered complete	2018 Year 11 Month 18 Day
Date analysis concluded	2018 Year 11 Month 27 Day

Other
Other related information	The aim is to examine the rate of complete resection of mucosal layer.

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032498

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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