Gastric Cancer
Conditions
Keywords
gastric cancer, procalcitonin
Brief summary
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
Interventions
OTHERgastric cancer pts undergoing surgery
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
Sponsors
University of Roma La Sapienza
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed * elective setting
Exclusion criteria
* age \< 18 years * pregnant women * patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP) | 2 years | PCT: procalcitonin, CRP: C-reactive protein |
| % of patients without leaks after gastric surgery correctly identified by PCT and CRP | 2 years | PCT: procalcitonin, CRP: C-reactive protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD | 2 years | procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV |
| PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD | 2 years | PCT cuts-off in 5th POD with a good NPV |
Countries
Italy
Contacts
Primary ContactValentina Giaccaglia, MD
Outcome results
None listed