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临床试验/NCT03780439
NCT03780439已完成不适用

Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study

Yongchang Zhang1 个研究点 分布在 1 个国家目标入组 552 人开始时间: 2018年6月1日最近更新:
适应症

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

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

发起方
Yongchang Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yongchang Zhang

Hunan Province Tumor Hospital

Hunan Province Tumor Hospital

研究点 (1)

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