NCT04724551

The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 648 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pancreas Neoplasm

Interventions

Type	Name	Description
PROCEDURE	pancreatoduodenectomy (PD)	A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.

Timeline

• Start date: 2012-06-01
• Primary completion: 2020-12-31
• Completion: 2021-02-28
• First posted: 2021-01-26
• Last updated: 2021-05-28