The Neutrophil-to-Lymphocyte Ratio To Exclude Pancreatic Fistula

Study Overview

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.

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).

Pancreas Neoplasm

PROCEDURE: pancreatoduodenectomy (PD)

NLR-IPC 2020-058

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-05-26
First Submitted that Met QC Criteria 2021-01-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-05-28
First Posted (ACTUAL) 2021-01-26	Results First Posted N/A	Last Verified 2021-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients who underwent pancreatoduodenectomy

Total pancreatectomy
Enucleation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Olivier Turrini, PD, Institut Paoli-Calmettes- (IPC)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record