The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Postoperative length of stay
研究概览
简要总结
Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.
详细描述
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced gastric cancer.
- •Age older than 18 and younger than 75 years.
- •American Society of Anesthesiologists (ASA) class: I-III.
- •Participants can describe the symptom objectively and cooperate actively.
- •Written informed consent
排除标准
- •Patients allergic to oxaliplatin, tegafur gimerac etc.
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
- •Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
- •Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
- •Patients who require simultaneous surgery for other diseases.
- •Patients who received upper abdominal surgery previously.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
NAC group
Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.
干预措施: NAC group (Procedure)
Surgery alone group
Patients will not receive NAC before the gastrectomy and ERAS.
干预措施: Surgery alone group (Procedure)
结局指标
主要结局
Postoperative length of stay
时间窗: 1 month
Postoperative length of stay
次要结局
- Total protein(1 week)
- Albumin(1 week)
- Time to semi-liquid diet(2 weeks)
- Postoperative complications(2 months)
- The time to first flatus(1 week)
- Prealbumin(1 week)
研究者
JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Jinling Hospital, China