Pancreatic cancer
Conditions
Interventions
Participants will be randomized to either perioperative prophylaxis (cefazolin,
metronidazole and a single dose of 5-7mg/kg gentamicin, control arm) or
perioperative prophylaxis followed by cefuroxi
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy. • Age of 18 years
Exclusion criteria
Exclusion criteria: • Pregnancy • Contraindication for the study antibiotics (e.g. allergy or intolerance) • Indication for endocarditis prophylaxis • Preoperative planned therapeutic antibiotic treatment after surgery (i.e. for cholangitis or liver abscesses) • A reduced renal function, defined as an eGFR of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the occurrence of a clinically relevant OSI and must meet the following criteria (based on the CDC definition): • A deep surgical site infection involving any part of the abdomen (e.g. organs and/or spaces) other than the surgical incision within 90 days after surgery. • AND Requires radiological, endoscopic or surgical intervention OR therapeutic antibiotics required for an episode of sepsis, defined as two or more SIRS criteria. • AND Organisms isolated from an aseptically obtained culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be evaluated between patients receiving perioperative prophylaxis versus pre-emptive antibiotic treatment (definitions are outlined in Appendix A): • OSI defined by the CDC definition within 90 days after surgery. • Isolated OSI defined as an OSI without concurrent anastomotic leakage (pancreatojejunostomy, hepaticojejunostomy or gastrojejunostomy). The concept of an isolated OSI is used to separately classify abdominal infections without concurrent anastomotic leakage. • Superficial incisional SSI: defined according to the CDC definition: a superficial surgical site infection occurring within 30 days after surgery which involves superficial or deep soft tissue (skin, muscle or fascia, but no intra-abdominal tissue), and at least one of the following criteria is present: - Purulent drainage from the incision or subcutaneous tissue. - Isolation of microorganisms from an aseptically obtained culture of fluid or tissue from the superficial incision of subcutaneous tissue. - Superficial infections of the skin or subcutaneous tissue which is deliberately opened by a surgeon or attending physician OR at least one of the following signs are present: localizes pain, tenderness, swelling, heat or fever >38 degrees). • Rate of clinically relevant postoperative pancreatic fistula (grade B or C defined according to the ISGPS definition. • Rate of bile and enteric leakage according to the ISGLS definition. • Rate of postpancreatectomy hemorrhage according to the ISGPS definition. • Rate of delayed gastric emptying according to the ISGPS definition. • Rate of chyle leak according to the ISGPS definition. • Rate of postoperative bacteraemia (defined as a positive blood culture) • Rate of Clostridium difficile infection • Rate of major complications, defined as a Clavien-Dindo score of >=III. • Reintervention during admission (either radiological, surgical or endoscopic). • ICU admission within 90 days after surger | — |
Countries
Netherlands
Outcome results
None listed