Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, procalcitonin
Brief summary
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
Interventions
OTHERpts operated for pancreatic cancer
measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection
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 pancreatic surgery * in elective setting * for cancer * with a pancreatic anastomosis performed.
Exclusion criteria
* age \< 18 years * pregnant women * patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic surgery without an anastomosis being performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | 2 yrs | Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak |
| Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | 2 yrs | Specificity: % of pts corrected identified by the biomarkers not having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCT and CRP cuts-off in 3rd POD with a good NPV for AL | 2 yrs | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value |
| PCT and CRP cuts-off in 5th POD with a good NPV for AL | 2 yrs | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value |
Countries
Italy
Contacts
Primary ContactValentina Giaccaglia, MD
Outcome results
None listed