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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029441
Receipt No. R000033632
Scientific Title Efficacy and safety of cold snare polypectomy with submucosal injection for small colorectal polyps. A randomized controlled study.
Date of disclosure of the study information 2017/10/27
Last modified on 2017/10/27

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Basic information
Public title Efficacy and safety of cold snare polypectomy with submucosal injection for small colorectal polyps. A randomized controlled study.
Acronym CSP-SI trial
Scientific Title Efficacy and safety of cold snare polypectomy with submucosal injection for small colorectal polyps. A randomized controlled study.
Scientific Title:Acronym CSP-SI trial
Region
Japan

Condition
Condition colorectal neoplastic polyp
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare efficacy and safety between cold snare polypectomy with and without submucosal injection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Complete muscularis mucosa resection rate
Key secondary outcomes The rate of lateral and vertical margin, intraprocedual bleeding major/minor delayed bleeding, perforation and fragmentation of resected specimens. Success rate of the allocated procedure.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cold snare polypectomy with submucosal injection
Interventions/Control_2 Conventional cold snare polypectomy without submucosal injection
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 Patients who has undergone colonoscopy within years and has one colorectal polyp endoscopically diagnosed as colorectal adenoma or sessile serrated adenoma/polyp (3mm-10mm)
Key exclusion criteria 1. Pregnancy
2. Inflammatory bowel disease, Familial polyposis
3. Bleeding tendency (Platelet count <80000/ul or prothrombin percentage activity <40%, PT-INR>3.0 among the patients with warfarin)
4. Multiple antithrombotic therapy
5. Poor bowel preparation
6. Invasive cancer
7. History of participant in this study
Target sample size 214

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Shimodate
Organization Kurashiki Central Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Email ys13544@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Shimodate
Organization Kurashiki Central Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Homepage URL
Email ys13544@kchnet.or.jp

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 27 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
2017 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 26 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
2021 Year 11 Month 30 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033632

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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