UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomised contorl study comparing the safety of cold snare polypectomy in patients with colorectal polyp below 10 mm at high versus low risk of bleeding
Title of the study (Brief title)	A study comparing the safety of CSP on warfarin v.s. warfarin plus antiplatelet agents
Region	Japan

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

Objectives
Narrative objectives1	To investigate the safety of cold snare polypectomy for colorectal polyp below 10mm in a randomized controlled trial comparing warfarin alone with adding warfarin to antiplatelet agents
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Delayed bleeding rate
Key secondary outcomes	Procedural bleeding control rate Procedure related adverse events Rate of residual tumor Incidence of perioperative arterial or venous thromboembolism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Cold snare polypectomy on warfarin
Interventions/Control_2	Cold snare polypectomy on warfarin and antiplatelet agents
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	1)20 y.o. or older 2)Patients with colorectal polyps <= 10mm 3)Patients who gave written informed consent 4)Patients who continued warfarin 5)Patients who continued both warfarin and antiplatelet agent
Key exclusion criteria	1)polyps >10mm 2)Patients with severe comorbidity 3)Patients during pregnancy 4)bleeding tendency except for a drug 5)others
Target sample size	180

Research contact person
Name of lead principal investigator	Naohiko Harada
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterology and Clinical Research Institute
Address	1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	haradan@kyumed.jp

Public contact
Name of contact person	Yorinobu Sumida
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Gastroenterology and Clinical Research Institute
Address	1-8-1 Jigyohama, Chuo-Ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	yorinobu@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyushu Medical Center
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 30 Day
Anticipated trial start date	2015 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 07 Month 05 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019920