Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- diagnostic accuracy of procalcitonin to detect post-operative infection
研究概览
简要总结
To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.
详细描述
From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical College were invited to participate in the study. After surgery, routine blood test were measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on POD 3 and 5.
The primary outcome of the present study was the accuracy of white blood cell (WBC) and neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (IAI), surgical site infections (SSIs), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. The main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed gastric adenocarcinoma
- •radical gastrectomy with lymphadenectomy.
排除标准
- •ongoing infection at surgery
- •pregnancy status
- •underwent non-resection surgery
- •underwent palliative gastrectomy
- •emergency surgery
- •taking corticosteroid or other immunosuppressive drugs
结局指标
主要结局
diagnostic accuracy of procalcitonin to detect post-operative infection
时间窗: within 30 days after surgery
the accuracy of procalcitonin to detect post-operative infection
次要结局
- diagnostic accuracy of procalcitonin to detect overall post-operative complications(within 30 days after surgery)
研究者
Yongchang Zhang
Hunan Province Tumor Hospital
Hunan Province Tumor Hospital
