The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula (NLR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Neoplasm
• Intervention / Treatment: Procedure: pancreatoduodenectomy (PD)

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).

• Study Type: Observational
• Enrollment (Actual): 648

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).

Description

Inclusion Criteria:

• Patients who underwent pancreatoduodenectomy

Exclusion Criteria:

• Total pancreatectomy
• Enucleation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically relevant pancreatic fistula	Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition	at hospital discharge assessed up to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2012
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatoduodenectomy; Pancreatic fistula; Neutrophil-to-Lymphocyte Ratio
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Pancreatic Fistula
• Other Study ID Numbers: NLR-IPC 2020-058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No