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临床试验/NCT04724551
NCT04724551已完成不适用

The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Institut Paoli-Calmettes0 个研究点目标入组 648 人开始时间: 2012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
648
主要终点
Incidence of clinically relevant pancreatic fistula

研究概览

简要总结

There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

详细描述

From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).

The cohort was split into 3 groups:

  • a training cohort ;
  • an internal validation cohort (Paoli Calmettes institute);
  • an external validation cohort (Rennes Pontchaillou Hospital).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 who underwent pancreatoduodenectomy

排除标准

  • Total pancreatectomy
  • Enucleation

结局指标

主要结局

Incidence of clinically relevant pancreatic fistula

时间窗: at hospital discharge assessed up to 30 days

Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition

次要结局

  • Biological markers(Postoperative day one and three)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

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