UMIN-CTR Clinical Trial

Basic information
Public title	A comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Acronym	Comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Scientific Title	A comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Scientific Title:Acronym	Comparison study of cold snare polypectomy and EMR for patients taking warfarin.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the safeness of cold snare polypectomy for colorectal polyps in patients taking warfarin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Delayed bleeding(within 2 weeks after procedure)
Key secondary outcomes	Immediate bleeding, adverse events other than bleeding, rate of complete resection.

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	YES
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	Maneuver
Interventions/Control_1	To perform cold snare polypectomy for colorectal polyps in patients taking warfarin.
Interventions/Control_2	To perform EMR 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients taking warfarin. 2. Patients who had colorectal polyps <10 mm,not suspected of early cancer,and not pedunculated .
Key exclusion criteria	1.Inflammatory bowel diseases 2. family polyposis 3.Hb< 9 g/dl 4.PT-INR>= 3 5.Pregnant women 6.Patients who undergo artificial dialysis 7.patients taking other anticoagulants 8.others
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Morita
Organization	Kobe University Hospital
Division name	Depertment of gastroenterology
Zip code	6500017
Address	7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL	078-382-5111
Email	ymorita@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Chika Middle name Last name Wakahara
Organization	Kobe University Hospital
Division name	Depertment of gastroenterology
Zip code	6500017
Address	7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL	078-382-5111
Homepage URL
Email	wakahara@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	None
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	Kobe
Address	Kobe
Tel	0783825652
Email	rinri@med.kobe-u.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	神戸大学医学部附属病院および関連病院群

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 02 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Terminated
Date of protocol fixation	2016 Year 03 Month 17 Day
Date of IRB	2016 Year 03 Month 17 Day
Anticipated trial start date	2016 Year 05 Month 02 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 17 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024817