UMIN-CTR Clinical Trial

Basic information
Public title	A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Acronym	A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Scientific Title	A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Scientific Title:Acronym	A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Region	Japan

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

Objectives
Narrative objectives1	To verify the superiority of direct oral anticoagulant replacement to heparin bridging in post polypectomy bleeding rate for patients who undergo endoscopic resection for colon polyps.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post polypectomy bleeding rate
Key secondary outcomes	Hospitalization, endoscopic treatment results, the rate of arterial thromboembolism, severe adverse events, endoscopic execution rate

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 adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Heparin bridging before endoscopic mucosal resection
Interventions/Control_2	direct oral anticoagulant replacement before endoscopic mucosal resection
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 who undergo endoscopic mucosal resection for colon polyps 2)Patients with non valvular atrial fibrillation, and use warfarin for prevention of thrombosis 3)PT-INR is less than 3.0 4)ages over 20 years 5)written informed consent
Key exclusion criteria	1)Plt is less than 50000/mm3 2)Patients who undergo hemodialysis 3)Woman who has a possibility of pregnancy or is during pregnancy 4)Impossible to suspend to one-antiplatelet medication. 5)The attending physician has determined that it is difficult to entry
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Yamada
Organization	National Hospital Organization Osaka National Hospital
Division name	Gastroenterology and Hepatology
Zip code	540-0006
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL	06-6942-1331
Email	yamada@onh.go.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Yamada
Organization	National Hospital Organization Osaka National Hospital
Division name	Gastroenterology and Hepatology
Zip code	540-0006
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL	06-6942-1331
Homepage URL
Email	yamada@onh.go.jp

Sponsor
Institute	National Hospital Organization
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Hospital Organization Headquarters Clinical Research Central Ethics Review Committee
Address	2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel	03-5712-5075
Email	700-kenkyu@mail.hosp.go.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	国立病院機構大阪医療センター（大阪府）、国立病院機構九州医療センター（福岡県）、国立病院機構呉医療センター・中国がんセンター（広島県）、国立病院機構東京医療センター（東京都）、国立病院機構三重中央医療センター（三重県）、国立病院機構災害医療センター（東京都）、国立病院機構函館病院（北海道）、国立病院機構北海道がんセンター（北海道）、国立病院機構金沢医療センター（石川県）、国立病院機構敦賀医療センター（福井県）、国立病院機構東広島医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 18 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	Completed
Date of protocol fixation	2016 Year 03 Month 04 Day
Date of IRB	2016 Year 04 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 16 Day
Last follow-up date	2018 Year 05 Month 30 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 04 Month 17 Day
Last modified on	2020 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025312