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
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	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 Yoji Middle name Last name Takeuchi
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code	5418567
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 Satoki Middle name Last name Shichijo
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code	5418567
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Homepage URL
Email	7satoki@oici.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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuo-ku, Osaka
Tel	06-6945-1181
Email	rinri01@opho.jp

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	https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.14824
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.14824
Number of participants that the trial has enrolled	188
Results	From August 2017 to October 2018, 188 patients were screened, and 357 polyps were included. CSDP was detected in 122/355 (34%) evaluated mucosal defects. Excluding five lesions requiring hemostasis immediately following CSP, 352 mucosal defects were biopsied. After excluding 102 biopsies containing normal mucosa, we evaluated 250 biopsies. The overall incidence of incomplete mucosal layer resection was 63% (159/250), 76% (68/90) with CSDP and 57% (91/159) without CSDP (P < 0.01).
Results date posted	2020 Year 01 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	From August 2017 to October 2018, 188 patients participated, and 357 polyps in 177 patients were resected by CSP.
Participant flow	We recruited patients who were scheduled to undergo colorectal polypectomy, and written informed consent was obtained for participation in this study. The exclusion criteria were inflammatory bowel disease, familial polyposis, antiplatelet drugs or anticoagulants that could not be discontinued according to the Japanese guidelines,10 abnormal coagulopathy, severe organ failure, and patients who were judged unsuitable by their primary doctors.
Adverse events	Postprocedural bleeding occurred in three patients and was managed endoscopically without blood transfusion. One bleeding incident originated from a study lesion, and the other two bleeding incidences followed endoscopic mucosal resection with electrocautery for polyps measuring 10 and 20 mm, respectively. No perforation or other adverse eventswere observed.
Outcome measures	The primary outcome was the incidence of incomplete mucosal layer resection (presence of muscularis mucosa or residual polyp in the biopsied specimen). Secondary outcomes were the incidence of CSDP, residual polyp in biopsied specimens, and any adverse event.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 19 Day
Date of IRB	2017 Year 07 Month 12 Day
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	2020 Year 01 Month 27 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
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Research case data
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