Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 10
- 主要终点
- Dosage of lipase in the drains
研究概览
简要总结
Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections.
To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences.
It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs.
In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients.
The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery.
The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.
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
- •Patients over 18
- •Patients undergoing scheduled pancreatic resection with or without anastomosis (cephalic duodenopancreatectomy, median pancreatectomy, left pancreatectomy, enucleation)
- •Patients able to understand instructions/information
- •Patients who have provided written informed consent
- •Patients with Health Insurance cover
排除标准
- •Patients with scheduled total pancreatectomy
- •Adults under wardship
- •Pregnant or breast-feeding women
- •Total pancreatectomy
- •Pancreatectomy not feasible
研究组 & 干预措施
Patient
干预措施: Lipase, amylase and CRP (C-reactive protein) dosages (Biological)
结局指标
主要结局
Dosage of lipase in the drains
时间窗: 3 days after surgical resection
次要结局
未报告次要终点
