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临床试验/NCT02784990
NCT02784990已完成不适用

Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions

Centre Hospitalier Universitaire Dijon10 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2016年6月3日最近更新:
适应症
干预措施

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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