UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma (<10mm) : a prospective cohort study.
Title of the study (Brief title)	A prospective cohort study of Cold polypectomy
Region	Japan

Condition
Condition	Colorectal adenoma <10mm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of cold snare, forceps polypectomy for colorectal adenoma <10mm.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Delayed bleeding
Key secondary outcomes	Immediate bleeding, Perforation, Procedure time, Endoscopical en bloc resection rate, Rate of advanced neoplasia

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 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Endoscopically diagnosed as colorectal adenoma <10mm 2)20 y.o< and 80 y.o> 3)Outpatient(Day surgery) 4)Written informed consent
Key exclusion criteria	1)20 y.o> or 80 y.o< 2)Pregnant 3)Pedunculated lesion 4)Patients with IBD, familial adenomatous polyposis 5)Patients with important organ failure 6)Patients with anticoagulant therapy, clopidogrel, ticlopidine, thrombin inhibitor, combination therapy of antiplatelet agents. 7)Poor bowel preparation 8)Patients undergoing polypectomy for colorectal polyp(>10mm) 9)Others
Target sample size	1200

Research contact person
Name of lead principal investigator	Yuichi Shimodate
Organization	Kurashiki Central Hospital
Division name	Department of gastroenterology
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Email	ys13544@kchnet.or.jp

Public contact
Name of contact person	Yuichi Shimodate
Organization	Kurashiki Central Hospital
Division name	Department of gastroenterology
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	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	倉敷中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 22 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 10 Month 31 Day
Date analysis concluded	2016 Year 11 Month 12 Day

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

Management information
Registered date	2014 Year 08 Month 10 Day
Last modified on	2016 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017222