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Completed

NCT Number: NCT04724551

The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

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.

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Key information

Conditions

Pancreas Neoplasm Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Fistula Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent pancreatoduodenectomy

Exclusion criteria

  • Total pancreatectomy
  • Enucleation

Treatment and study plan

pancreatoduodenectomy (PD)

Procedure

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

Primary outcomes

  1. Incidence of clinically relevant pancreatic fistula

    Time frame: 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 outcomes

  1. Biological markers

    Time frame: Postoperative day one and three

    Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: NLR

Important dates

Study start
2012
Primary completion
2020
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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