NCT05543863招募中不适用
Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents
Kyungpook National University Chilgok Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- platelet function testing at 5 days
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
platelet function testing at 5 days
时间窗: 5 days
Difference in the platelet function testing results between before and 5 days after surgery.
次要结局
- postoperative complications(3 months)
- Platelet function testing at 3 months(3 months)
研究者
Ji Yeon Park
Principle Investigator (Associate professor)
Kyungpook National University Chilgok Hospital
研究点 (1)
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