Cardiovascular Diseases, Cerebrovascular Disease, Stomach Neoplasm
Conditions
Brief summary
This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.
Interventions
DIAGNOSTIC_TESTPlatelet function testing
platelet function testing (Platelet function analyzer-100 (PFA-100) collagen epinephrine closure time, VerifyNowⓇ Assays (aspirin, P2Y12)) before surgery and 5 days, 3 months after surgery
Sponsors
Kyungpook National University Chilgok Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition. * Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery) * Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery. * age 18 - 90 years * A person who voluntarily agrees to participate in this study and signs the consent form.
Exclusion criteria
* Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT) * Patients taking other anticoagulants in combination * Patients with imparied liver or renal function that may affect drug metabolism. Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher * Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition) * Patients participating in other clinical trials within 6 months * Vulnerable patients (pregnant women, those with cognitive impairment, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet function testing at 5 days | 5 days | Difference in the platelet function testing results between before and 5 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet function testing at 3 months | 3 months | Difference in the platelet function testing results between before and 3 months after surgery |
| postoperative complications | 3 months | ■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery |
Countries
South Korea
Contacts
Primary ContactJi Yeon Park, MD
Backup ContactSoye An
Outcome results
None listed