UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic mucosal resection of colorectal polyp in anticoagulated patients
Title of the study (Brief title)	EMR in anticoagulated patients
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 colonic EMR without a heparin bridge in anticoagulated patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	perioperative and postoperative bleeding ( until 30 days after procedure)
Key secondary outcomes	thromboembolism( until 30 days after procedure) variables as bleeding risk factor comparison between warfarin and DOAC

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	Colorectal EMR in anticoagulated patients (until 30 days after procedure)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients with colorectal polyp becoming the indication of EMR: 2) Under single use of anticoagulant agent 3) PT-INR is less than 2.6 4) Written Informed consent.
Key exclusion criteria	1) PT-INR is 2.6 or more 2) Under combination use of antiplatelet agents. 3) patients with severe organ failure (herat, liver,renal) 4) patients who have been judged as inappropriate for this study
Target sample size	90

Research contact person
Name of lead principal investigator	Sayo Kobayashi
Organization	Fukuyama City Hospital
Division name	Department of Internal medicine
Address	5-23-1 Zao-cho Fukuyama-city Hiroshima
TEL	084-941-5151
Email	sayo44@hotmail.co.jp

Public contact
Name of contact person	Sayo Kobayashi
Organization	Fukuyama City Hospital
Division name	Department of Internal medicine
Address	5-23-1 Zao-cho Fukuyama-city Hiroshima
TEL	084-941-5151
Homepage URL
Email	sayo44@hotmail.co.jp

Sponsor
Institute	Fukuyama City Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Okayama University Hospital, Okayama saiseikai General Hospital, Mitoyo General Hospital, Kagawa Prefectural Central Hospital, Okayama City Hospital, Tsuyama Chuo Hospital, Okayama Red Cross Hospital, Sumitomo Besshi Hospital, Himeji Red Cross Hospital, Hiroshima City Hospital, Fukuyama Medical Center,
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	福山市民病院（広島県）岡山大学病院(岡山県), 岡山済生会総合病院(岡山県), 三豊総合病院（香川県）, 香川県立中央病院（香川県）, 岡山市立市民病院(岡山県), 津山中央病院(岡山県), 岡山赤十字病院(岡山県), 住友別紙病院（愛媛県）, 姫路赤十字病院（兵庫県）, 広島市立広島市民病院（広島県）, 福山医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 02 Day
Anticipated trial start date	2016 Year 03 Month 09 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	2016 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024504