The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula
- Conditions
- Pancreas Neoplasm
- Registration Number
- NCT04724551
- Lead Sponsor
- Institut Paoli-Calmettes
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 648
- Patients who underwent pancreatoduodenectomy
- Total pancreatectomy
- Enucleation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of clinically relevant pancreatic fistula at hospital discharge assessed up to 30 days Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition
- Secondary Outcome Measures
Name Time Method Biological markers Postoperative day one and three Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula