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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044309
Receipt No. R000050570
Scientific Title Evaluation of complete cold snare polypectomy resection rate for 6- to 9-mm colorectal sessile serrated lesions
Date of disclosure of the study information 2021/07/01
Last modified on 2021/05/24

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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

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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