臨床研究等提出・公開システム

Scientific Title	Evaluation of complete cold snare polypectomy resection rate for 6- to 9-mm colorectal sessile serrated lesions (CS-CSP study)
Public Title	Evaluation of complete cold snare polypectomy resection rate for 6- to 9-mm colorectal sessile serrated lesions (CS-CSP study)

Contact for Scientific Queries	Name	Yamasaki Yasushi
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama
	Telephone	+81-86-235-7219
	E-mail	yasshifive@yahoo.co.jp
Contact for Public Queries	Name	Yamamoto Shumpei
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama
	Telephone	+81-86-235-7219
	E-mail	ysyunpei@hotmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 24, 2021
Actual date of first enrollment
Target sample size		134
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Sessile serrated lesions 6-9mm in size
	Exclusion Criteria	Suspicious of cancer or adenoma Familial adenomatous polyposis Inflammatory bowel disease Infectious disease with systemic therapy indicated Pregnant or nursing Impossible to perform UEMR due to antithrombotic drugs Short prognosis (within one year) Other inappropriate cases
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		colorectal sessile serrated lesion
Intervention(s)		Perform CSP for SSL. In addition, perform EMR for lesion after CSP.
Health Condition(s) Keyword		colorectal sessile serrated lesion
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Complete resection rate
Secondary Outcome(s)		The residual rate to horizon/vertical stump The rate of CSDP (Cold snare defect protrusion) Times of CSP Complete resection rate according to the SSL size Procedure time Adverse events Histology

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Okayama
Telephone	+81-86-235-6938
E-Mail	mae6605@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	July. 27, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none