UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of complete cold snare polypectomy resection rate for 6- to 9-mm colorectal sessile serrated lesions
Acronym	CS-CSP study
Scientific Title	Evaluation of complete cold snare polypectomy resection rate for 6- to 9-mm colorectal sessile serrated lesions
Scientific Title:Acronym	CS-CSP study
Region	Japan

Condition
Condition	colorectal sessile serrated lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of cold snare polypectomy (CSP) for colorectal sessile serrated lesion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Complete resection rate
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cold Snare Polypectomy
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Sessile serrated lesions 6-9mm in size
Key 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
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Yamasaki
Organization	Okayama University Hospital
Division name	Gastroenterology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL	+81-86-235-7219
Email	yasshifive@yahoo.co.jp

Public contact
Name of contact person	1st name Shumpei Middle name Last name Yamamoto
Organization	Okayama University Hospital
Division name	Gastroenterology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL	+81-86-235-7219
Homepage URL
Email	ysyunpei@hotmail.com

Sponsor
Institute	Okayama University Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	Okayama University Hospital
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	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
Tel	+81-86-235-7361
Email	ouh-crrb@adm.okayama-u.ac.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	2021 Year 07 Month 01 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	2021 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 24 Day
Last modified on	2021 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050570