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Background. Pancreatic cancer surgery is associated with very high risk of postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).
Purpose. The investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after pancreatic surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pts operated for pancreatic cancer | all pts operated of pancreatic resection for cancer in the involved units |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pts operated for pancreatic cancer | Other | measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak | 2 yrs |
| Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | Specificity: % of pts corrected identified by the biomarkers not having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak | 2 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| PCT and CRP cuts-off in 3rd POD with a good NPV for AL | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value | 2 yrs |
| PCT and CRP cuts-off in 5th POD with a good NPV for AL |
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Inclusion Criteria:
Exclusion Criteria:
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all pts undergoing pacreatic resections for cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Giaccaglia, MD | Contact | +393397882429 | v.giaccaglia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sant'Andrea University Hospital | Recruiting | Rome | 00189 | Italy |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value
| 2 yrs |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |