gastric cancer
Conditions
Interventions
In the perioperative period, we change the anticoagulant (warfarin, rivaroxaban, apixaban, edoxaban) to dabigatran and performe ESD to gastric neoplasms.
Sponsors
Cancer Institute Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Having gastric cancer indicated ESD according to Japanese guideline 2 Over 20 years old 3 Performance status of 0-3 4 Having non- valvular Af in CHADS-2 score of 0-4 5 Taking warfarin, rivaroxaban, or apixaban continuously for prophylactics of thrombotic events, over 28 days before registration 6 Patients on antiplatelet agents such as aspirin or thienopyridine are not excluded. 7 Over 30 mL/min of CCr (or over 30mL/min/1.73m2 of EGFR) in examination within 56 days from registration 8 Over 10g/dl of Hb and over 5x104/mm3 of platelet count within 56 days from registration without transfusion in 14 days. 9 Able to observe patient for 56 days after ESD 10 Obtained a consent from prescribing doctor of anticoagulant 11 Obtained a consent from the patient
Exclusion criteria
Exclusion criteria: 1 Patients with non-valvular Af in CHADS2 score of 5 or 6 2 Have allergy for dabigatran 3 Have a plan to perform endoscopic resection for esophageal or duodenal lesion simultaneously 4 Had endoscopic treatment within 28 days from registration 5 Have infection requiring systemic treatments 6 Being or possible pregnant 7 Having psychiatric disorder and judged unsuitable for the clinical study. 8 Continuous systemic use of steroid 9 Using itraconazole which is contraindications of combination with dabigatran 10 Unstable angina (newly occurring or a worsening over the 3 weeks prior to ESD) or myocardial infarction within 6 months prior to ESD 11 Severe respiratory disease requiring continuous oxygen supply 12 Uncontrollable hypertension 13 Uncontrollable diabetes mellitus 14 Patients judged unsuitable for clinical study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed bleeding rate of all registered cases | — |
Secondary
| Measure | Time frame |
|---|---|
| THe rate of throbmbotic events of all cases, Delayed bleeding rate for each cases, The duration of hospitalization, The rate of severe complications. | — |
Countries
Japan
Contacts
Public ContactToshiyuki Yoshio
Cancer Institute Hospital Gastroenterology
Outcome results
None listed