The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

648 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-01

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Pancreas Neoplasm

Keywords

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Pancreatic fistula Neutrophil-to-Lymphocyte Ratio Pancreatoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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pancreatoduodenectomy (PD)

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent pancreatoduodenectomy

Exclusion Criteria

* Total pancreatectomy
* Enucleation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Turrini, PD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes- (IPC)

Other Identifiers

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NLR-IPC 2020-058

Identifier Type: -

Identifier Source: org_study_id