UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Title of the study (Brief title)	A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Region	Japan

Condition
Condition	colon polyps of patients who have non valvular atrial fibrillation and use warfarin for the prevention of thrombosis
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety of polypectomy/EMR(Endoscopic Mucosal Resection) of colon without cessation of warfarin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The bleeding rate after polypectomy/EMR from immediately to the 28th day after polypectomy/EMR.
Key secondary outcomes	1.Early bleeding rate after polypectomy/EMR (from immediately after polypectomy/EMR to before the day2 meal starts) 2. Delayed bleeding rate after polypectomy/EMR (after the day2 meal has started) 3.Bleeding rate after polypectomy/EMR by the the tumor site and the major axis of tumor 4.The rate and number of blood transfusion for the bleeding during the polypectomy/EMR 5.The rate and number of blood transfusion for the bleeding after the polypectomy/EMR 6.PT-INR at the time of bleeding after polypectomy/EMR 7.Complications and the bleeding rate after polypectomy/EMR 8.Length of hospitalization

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In patients who have non valvular atrial fibrillation and use warfarin for prevention of thrombosis, colorectal polypectomy/EMR wil be performed without cessation of warfarin. Protocol treatment period in this study is from the day of polypectomy/EMR(day0) to the 28th day after polypectomy/EMR(day28). Observation period is from the registration to the protocol to the end of protocol treatment period.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with non valvular atrial fibrillation, and use warfarin for prevention of thrombosis. Patients' PS (Performance Status) is 0-2 of ECOG(Eastern Cooperative Oncology Group), and over 20 years old age. The target is colorectal polyp that is indicated in polypectomy or EMR in Japanese colon polyp practice guidelines 2014. (1)In blood collection within 3days before the treatment, PT-INR has to be confirmed following values. Less than 70 years of age:PT-INR is less than 3 70 years of age or older: PT-INR is less than 2.6 (2)CCr is confirmed greater than or equal to 50mL/min(Cockcroft-Gault Equation) at the day before treatment. (3)After the patient himself has received a sufficient explanation on participation in this study, informed consent has been obtained by the free will of the patient him or herself. (4)It is possible to follow the course of more than 28 days after treatment. (5)All the following test data using the latest test values within 30 days prior to registration is met. a)Hb is 9g/dl or more b)Plt is 100000/mm3 or more c)AST, ALT is less than 100IU/L d)APTT is less than 40sec
Key exclusion criteria	(1)CCr is less continuously 50mL/min (Cockcroft-Gault Equation) (2)Woman who has a possibility of pregnancy or is during pregnancy (3)Woman who nurses her baby (4)Patients who undergo hemodialysis (5)To assess the general condition and complications of patients, if the attending physician has determined that it is difficult to entry.
Target sample size	30

Research contact person
Name of lead principal investigator	Satoshi Ono
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	satoshi-tky@umin.ac.jp

Public contact
Name of contact person	Itaru Saito
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	isaitou-nms@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Institute
Department

Funding Source
Organization	This study will be performed with medical care insurance. The clinical research insurance will be covered by donation (donation number 104-41).
Organization
Division
Category of Funding Organization	Other
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	石川県立中央病院(石川県)、茨城県立中央病院(茨城県)、大阪府立急性期・総合医療センター(大阪府)、静岡県立静岡がんセンター(静岡県)、千葉西総合病院(千葉県)、筑波学園病院(茨城県)、新潟県立中央病院(新潟県)、日立総合病院(茨城県)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 16 Day
Anticipated trial start date	2014 Year 12 Month 26 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 30 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2017 Year 03 Month 01 Day

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

Management information
Registered date	2014 Year 12 Month 26 Day
Last modified on	2017 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018662