The lesion that is indicated in gastric endoscopic submucosal dissection in patients who use warfarin for prevention of thrombosis.
Conditions
Interventions
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
Sponsors
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bleeding rate after gastric endoscopic submucosal dissection from immediately until the 28th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactItaru Saito
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Outcome results
None listed