Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents

Conditions
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Stomach Neoplasm, Cardiovascular Diseases, Cerebrovascular Disease

Intervention / Treatment
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* Diagnostic Test: Platelet function testing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Platelet 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet function testing at 5 days | Difference in the platelet function testing results between before and 5 days after surgery. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function testing at 3 months | Difference in the platelet function testing results between before and 3 months after surgery | 3 months | 
| postoperative complications | ■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery | 3 months |