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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreatoduodenectomy (PD) | Procedure | A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biological markers | Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula | Postoperative day one and three |
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Inclusion Criteria:
Exclusion Criteria:
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3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Turrini, PD | Institut Paoli-Calmettes- (IPC) | Principal Investigator |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |