UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Acronym	Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Scientific Title	Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Scientific Title:Acronym	Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Region	Japan

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

Objectives
Narrative objectives1	Comparing the safety and efficacy of CSP for the treatment of SSLs larger than 10 mm performed by both expert and non-expert
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	complete resection rate, en bloc resection rate, adverse event rate, and procedure time
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with 10mm or more SSL
Key exclusion criteria	Lesions with the following endoscopic findings associated with cytological dysplasia or cancer
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Kimoto Middle name Last name Yoshiaki
Organization	NTT Medical Center Tokyo
Division name	Division of Gastrointestinal Endoscopy
Zip code	141-8625
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL	03-3448-6111
Email	kimoto.yoshiaki@gmail.com

Public contact
Name of contact person	1st name Kimoto Middle name Last name Yoshiaki
Organization	NTT Medical Center Tokyo
Division name	Division of Gastrointestinal Endoscopy
Zip code	141-8625
Address	5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL	03-3448-6111
Homepage URL
Email	kimoto.yoshiaki@gmail.com

Sponsor
Institute	NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization	None
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	NTT Medical Center Tokyo
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
Tel	03-3448-6111
Email	kimoto.yoshiaki@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	No. 18-81
Org. issuing International ID_1	NTT Medical Center Tokyo
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 11 Month 26 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 13 Day
Date of IRB	2018 Year 11 Month 13 Day
Anticipated trial start date	2018 Year 11 Month 13 Day
Last follow-up date	2028 Year 11 Month 13 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 11 Month 26 Day
Last modified on	2021 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052730