UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of cold snare polypectomy for colorectal polyps 14 mm in size
Title of the study (Brief title)	Safety of cold snare polypectomy for colorectal polyps
Region	Japan

Condition
Condition	colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety of cold snare polypectomy in patients including patients antithrombotic therapy is analyzed. Additionally, local recurrence is analyzed in cases with follow-up.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative hemorrhage
Key secondary outcomes	The rate of local recurrence

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Cases with colorectal polyps less than 14 mm in size diagnosed as adenoma or sessile serrated adenoma and polyp
Key exclusion criteria	Cases with severe main organ disease
Target sample size	900

Research contact person
Name of lead principal investigator	Naito Yuji
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	naohsia@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	京都府立医科大学附属病院(京都府)、市立福知山市民病院(京都府)、綾部市立病院(京都府)、京都九条病院(京都府)、京都北部医療センター(京都府)、松下記念病院(大阪府)、朝日大学村上記念病院(岐阜県)、舞鶴医療センター(京都府)、西陣病院(京都府)、京都第一赤十字病院(京都府)、京都市立病院(京都府)、京都鞍馬口医療センター(京都府)、大津市民病院(滋賀県)

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 12 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observation study

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022340