UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Title of the study (Brief title)	A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Region	Japan

Condition
Condition	The lesion that is indicated in gastric endoscopic submucosal dissection in patients who use warfarin for prevention of thrombosis.
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety of gastric endoscopic submucosal dissection 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 gastric endoscopic submucosal dissection from immediately until the 28th day
Key secondary outcomes	1.The existence of bleeding requiring hemostatic procedure in second-look gastrointestinal endoscopy (day1). 2.Early bleeding rate after gastric endoscopic submucosal dissection (from immediately after gastric endoscopic submucosal dissection to before the day2 meal starts). 3.Delayed bleeding rate after gastric endoscopic submucosal dissection (after the day2 meal started). 4.Duration 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 use warfarin for prevention of thrombosis, gastric endoscopic submucosal dissection will be done without cessation of warfarin. Protocol treatment period in this study is from the day of gastric endoscopic submucosal dissection (day0) to the 28th day after gastric endoscopic submucosal dissection (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. (1)The target is the lesion that is indicated in endoscopic submucosal dissection in Japanese classification of gastric carcinoma: 4th Japanese edition 2014. (2) a)In patients with non valvular atrial fibrillation, PT-INR has to be confirmed following values in blood collection within 3days before the treatment. 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 b)In patients using warfarin for the prevention of deep vein thrombosis or pulmonary embolism, PT-INR has to be confirmed following values in blood collection within 3days before the treatment. PT-INR is less than 2.5 c)In patients with artificial heart valve, PT-INR has to be confirmed following values in blood collection within 3days before the treatment. PT-INR is less than 3.0 (3)Estimated glomerular filtration (eGFR) is confirmed greater than or equal to 30mL/min/1.73m2 within 60 days prior to registration. (4)After the patient has received a sufficient explanation on participation in this study, informed consent has been obtained by the free will of the patient. (5)It is possible to follow the course of more than 28 days after treatment. (6)All the following test data using the latest test values within 60 days prior to registration is met. 1) Hb is 9g/dl or more 2) Plt is 100000/mm3 or more 3) AST, ALT is less than 100IU/L
Key exclusion criteria	(1)Women who has a possibility of pregnancy or is during pregnancy (2)Women who has baby and is nursing (3)Patients who undergo hemodialysis (4)To assess the general condition and complications of patients, if the attending physician has determined that it is difficult to entry.
Target sample size	15

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	+81-3-3815-5411
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	+81-3-3815-5411
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	The clinical research insurance is covered by Grant-in-Aid for Scientific Research- Young Scientists (B) (Principal Investigator: Satoshi Ono, project number: 127100000551).
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 04 Day

Progress
Recruitment status
Date of protocol fixation	2015 Year 12 Month 17 Day
Anticipated trial start date	2016 Year 03 Month 01 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 02 Month 02 Day
Last modified on	2018 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024062