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NLR: The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Completed
CT.gov ID
NCT04724551
Collaborator
(none)
648
Enrollment
104.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
648 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Actual Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Feb 28, 2021

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Biological markers [Postoperative day one and three]

    Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who underwent pancreatoduodenectomy
Exclusion Criteria:

  • Total pancreatectomy

  • Enucleation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Olivier Turrini, PD, Institut Paoli-Calmettes- (IPC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT04724551
Other Study ID Numbers:
  • NLR-IPC 2020-058
First Posted:
Jan 26, 2021
Last Update Posted:
May 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Paoli-Calmettes
Pancreatic fistula
Neutrophil-to-Lymphocyte Ratio
Pancreatoduodenectomy
Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatic Fistula
Fistula

Study Results

No Results Posted as of May 28, 2021