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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04724551

Acronym

NLR

Enrollment

648

Registered

2021-01-26

Start date

2012-06-01

Completion date

2021-02-28

Last updated

2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Neoplasm

Keywords

Pancreatic fistula, Neutrophil-to-Lymphocyte Ratio, Pancreatoduodenectomy

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).

Interventions

PROCEDUREpancreatoduodenectomy (PD)

A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who underwent pancreatoduodenectomy

Exclusion criteria

* Total pancreatectomy * Enucleation

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Biological markers	Postoperative day one and three	Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026