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NCT04724551 Clinical Trial

The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

Pancreas Neoplasm Clinical Trial

— NLR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04724551
Other study ID # NLR-IPC 2020-058
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2012
Est. completion date February 28, 2021

Study information
Verified date January 2021
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 648
Est. completion date February 28, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who underwent pancreatoduodenectomy Exclusion Criteria: - Total pancreatectomy - Enucleation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreatoduodenectomy (PD)
A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

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