Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- % of patients without leaks after gastric surgery correctly identified by PCT and CRP
研究概览
简要总结
Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).
Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
- •elective setting
排除标准
- •age < 18 years
- •pregnant women
- •patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed
结局指标
主要结局
% of patients without leaks after gastric surgery correctly identified by PCT and CRP
时间窗: 2 years
PCT: procalcitonin, CRP: C-reactive protein
% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)
时间窗: 2 years
PCT: procalcitonin, CRP: C-reactive protein
次要结局
- PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD(2 years)
- PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD(2 years)
研究者
Valentina Giaccaglia
MD
University of Roma La Sapienza