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Background. Gastric cancer surgery is associated with high risk for 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. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gastric cancer pts undergoing surgery | all pts receiving gastric resection for cancer, with anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastric cancer pts undergoing surgery | Other | Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP) | PCT: procalcitonin, CRP: C-reactive protein | 2 years |
| % of patients without leaks after gastric surgery correctly identified by PCT and CRP | PCT: procalcitonin, CRP: C-reactive protein | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD | procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV | 2 years |
| PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing gastric cancer surgery in our institution
| 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 |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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PCT cuts-off in 5th POD with a good NPV |
| 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |