UMIN-CTR Clinical Trial

Basic information
Public title	usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Acronym	usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Scientific Title	usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Scientific Title:Acronym	usefulness of cold snare polypectomy for patients taking novel oral anticoagulant and warfarin
Region	Japan

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

Objectives
Narrative objectives1	To clarify the usefulness and safeness of cold snare polypectomy for colorectal polyps in patients who are prescribed NOAC or warfarin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	late bleeding(within 2 weeks after procedure)
Key secondary outcomes	early bleeding; adverse events other than bleeding; rate of complete resection

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	Maneuver
Interventions/Control_1	To perform cold snare polypectomy for colorectal polyps in patients taking NOAC.
Interventions/Control_2	To perform cold snare polypectomy for colorectal polyps in patients taking warfarin.
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1.patients with colorectal polyps who are going to receive endoscopic resection. 2.the polyp is no larger than 10mm, not suspected of high grade or early cancer, and not Ip in morphology. 3.patietns who are taking NOAC or warfarin. 4.NOAC includes dabigatran, rivaroxaban , apixaban, and edoxaban.
Key exclusion criteria	1.combination use of antiplatelet agents. 2.history of inflammatory bowel disease. 3.Patients with severe heart failure, renal failure, psychiatric disorder, liver failure. 4.pregnancy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	takma_h@yokohama-cul.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatorogy
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	takuma_h@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yokohama City University Hospital IRB
Address	3-9 Fukuura Kanazawa-ku Yokohama City
Tel	045-787-2640
Email	umezawa-ykh@umin.ac.jp

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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 07 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	90
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Delay of analysis
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	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 01 Day
Date of IRB	2015 Year 12 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 12 Month 07 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023223