UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Complete resection rate of cold snare polypectomy: a randomized controlled trial
Title of the study (Brief title)	Complete resection rate of cold snare polypectomy: a randomized controlled trial (CRESCENT study)
Region	Japan

Condition
Condition	colon polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps <10 mm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Complete resection rate of polypectomy
Key secondary outcomes	Rate of post-polypectomy bleeding Polyp retrieval rate Number of times of additional snaring Ratio of difficult case to remove polyps by cold snare polypectomy Procedure time

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Cold snare polypectomy
Interventions/Control_2	Hot snare polypectomy (Endoscopic mucosal resection)
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 had colorectal adenomatous polyps <10 mm.
Key exclusion criteria	Inflammatory bowel diseases Familial polyposis Patients who take anticoagulants Pregnant women Patients who undergo artificial dialysis Patients who are classified >ASA classIII Others
Target sample size	780

Research contact person
Name of lead principal investigator	KAWAMURA Takuji
Organization	Kyoto Second Red Cross Hospital
Division name	Department of Gastroenterology
Address	355-5, Haruobi-cho, Kamigyo-ku, Kyoto, JAPAN
TEL	075-231-5171
Email	kawamurat@kyoto2.jrc.or.jp

Public contact
Name of contact person	KAWAMURA Takuji
Organization	Kyoto Second Red Cross Hospital
Division name	Department of Gastroenterology
Address	355-5, Haruobi-cho, Kamigyo-ku, Kyoto, JAPAN
TEL	075-231-5171
Homepage URL
Email	kawamurat@kyoto2.jrc.or.jp

Sponsor
Institute	Kyoto Second Red Cross Hospital
Institute
Department

Funding Source
Organization	Kansai Endoscopic Device Selection Study Group Investigator Sponsored Research Program of Boston Scientific
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	大阪医科大学　(大阪府） 大阪府立成人病センター　（大阪府） 関西医科大学　（大阪府） 北野病院　（大阪府） 京都第二赤十字病院　（京都府） 近畿大学　（大阪府） 神戸大学　（兵庫県） 佐野病院　（兵庫県） 滋賀医科大学　（滋賀県） 市立豊中病院　（大阪府） 多根総合病院 （大阪府） 奈良県立医科大学 （奈良県） 日本赤十字社和歌山医療センター　（和歌山県） ベルランド総合病院　（大阪府） 淀川キリスト教病院　（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 16 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 09 Month 26 Day
Date analysis concluded	2016 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://gut.bmj.com/content/early/2017/09/28/gutjnl-2017-314215
Results	The complete resection rate for CSP is not inferior to that for HSP. CSP can be one of the standard techniques for 4-9？mm colorectal polyps.
Other related information

Management information
Registered date	2015 Year 07 Month 15 Day
Last modified on	2017 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021212