Pancreatic Cancer Clinical Trial
— SPARROWOfficial title:
Standard Versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes After Whipple's Procedure (SPARROW): a Multicenter, Randomized Controlled Trial
The goal of this multicenter randomized controlled trial is to evaluate the additional value of pre-emptive antibiotic treatment on clinically relevant organ/space surgical site infections (OSIs) in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile. The main objectives it aims to answer are: - To evaluate the effect of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile - To evaluate the effect of pre-emptive antibiotic prophylaxis on other postoperative outcomes (e.g. OSIs, superficial SSIs, POPF, PPH, major morbidity, ICU admission, readmission, length of hospital stay, and mortality). - To evaluate concordance between perioperatively obtained bile cultures and postoperative cultures from infectious sites, and to evaluate antibiotic sensitivity patterns of the cultured microorganisms. Participants will be randomized with a 1:1 allocation before surgery into the intervention or control group: - Patients in the intervention group will receive perioperative prophylaxis (similar to the control group) followed by five days of 1500mg IV cefuroxime and 500mg IV metronidazole thrice daily. - Patients in the control group will only receive perioperative prophylaxis (a single dose of 5-7mg/kg gentamicin followed by 2gr IV cefazolin and 500mg IV metronidazole every 4h of surgery), which will be discontinued after surgery.
Status | Recruiting |
Enrollment | 322 |
Est. completion date | January 2026 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 >18 years Exclusion Criteria: - Pregnancy - Contraindication for the study antibiotics (e.g. allergy or intolerance) - Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Center | Amsterdam | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | Medisch Spectrum Twente | Enschede | |
Netherlands | Groningen University Medical Center | Groningen | |
Netherlands | Leiden University Medical Center | Leiden | Zuid Holland |
Netherlands | Maastricht University Medical Center | Maastricht | |
Netherlands | Radboud University Medical Center | Nijmegen | |
Netherlands | Erasmus MC Cancer Institute | Rotterdam | |
Netherlands | Regional Academic Cancer Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The percentage of patients with a deviation from antibiotic study protocol | Study protocol:
Control arm: Perioperative antibiotic prophylaxis (cefazolin, metronidazole and single-dose gentamicin). Intervention arm: Perioperative plus prolonged antibiotics (cefuroxime and metronidazole for five postoperative days). |
5 days | |
Other | Antibiotic sensitivity patterns of microorganisms cultured from bile cultures and postoperative cultures from infectious sites between patients with perioperative versus prolonged antibiotic prophylaxis | Rate of Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites | 90 days | |
Other | The percentage of concordance of microorganisms in bile and cultures from infectious sites postoperatively | Defined as the similarity of microorganisms between perioperative bile cultures and postoperative cultures from infectious sites. | 90 days | |
Primary | Rate of clinically relevant organ/space surgical site infection (OSI) between patients with perioperative versus prolonged antibiotic prophylaxis | A clinically relevant OSI is defined by the following criteria:
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. |
90 days after surgery | |
Secondary | The rate of organ/Space Infection (OSI) between patients with perioperative versus prolonged antibiotic prophylaxis | An OSI is defined by the CDC definition:
o The infection appears to be related to the operative procedure and infection involves any part of the anatomy (e.g., organs or spaces) other than the incision opened or manipulated during the operative procedure, and at least one of the following is present: Purulent drainage from a drain that is placed into the organ/space. Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space. An abscess or other evidence of infection involving the organ/space on direct examination, during reoperation, or by histopathologic or radiologic examination. Diagnosis of an organ/space SSI by a surgeon or attending physician." |
90 days | |
Secondary | The rate of isolated OSI between patients with perioperative versus prolonged antibiotic prophylaxis | Isolated OSI is 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. | 90 days | |
Secondary | The rate of superficial incisional SSI between patients with perioperative versus prolonged antibiotic prophylaxis | A superficial surgical site infection 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). |
90 days | |
Secondary | The rate of clinically relevant postoperative pancreatic fistula between patients with perioperative versus prolonged antibiotic prophylaxis | Grade B or C postoperative pancreatic fistula (POPF) defined by the International Study Group of Pancreatic Surgery definition:
Grade A: Amylase >3 times upper limit of the institutional normal serum amylase value Grade B: Grade A + persistant drainage >3 weeks, clinically relevant change in management of POPF, percutaneous or endoscopic drainage, angiographic procedures for bleeding, or signs of infection without organ failure. Grade C: Grade A or B requiring reoperation, resulting in organ failure or death. |
90 days | |
Secondary | The rate of bile leakage between patients with perioperative versus prolonged antibiotic prophylaxis | Grade A, B or C defined by the ISGLS definition:
Grade A: Bile leakage requiring no or little change in patients' clinical management. Grade B: Bile leakage requiring a change in patients clinical management (eg, additional diagnostic or interventional procedures) but manageable without relaparotomy, or a Grade A bile leakage lasting for >1 week. Grade C: Bile leakage requiring relaparotomy |
90 days | |
Secondary | The rate of post pancreatectomy hemorrhage between patients with perioperative versus prolonged antibiotic prophylaxis | Grade A, B or C defined by the ISGPS definition:
Grade A: Early (<24h after surgery), intra- or extraluminal, clinically mild. Grade B: Early (<24h after surgery), intra- or extraluminal and clinically severe OR later (>24h after surgery), intra- or extraluminal and clincally mild. Grade C: Late (>24h after surgery), intra- or extraluminal and clinically severe. |
90 days | |
Secondary | The rate of delayed gastric emptying between patients with perioperative versus prolonged antibiotic prophylaxis | Grade A, B or C defined by the ISGPS definition:
Grade A: Until day 4-7 or replacement of feeding tube > 3 days after surgery Grade B: Until day 8-14 or replacement of feeding tube > 7 days after surgery Grade C: >day 14 or replacement of feeding tube > 14 after surgery |
90 days | |
Secondary | The rate of postoperative bacteremia between patients with perioperative versus prolonged antibiotic prophylaxis | Defined as a positive blood culture obtained during a septic period (defined as two or more SIRS criteria) | 90 days | |
Secondary | The rate of Clostridium difficile infection between patients with perioperative versus prolonged antibiotic prophylaxis | Defined by a positive fecal culture for Clostridium difficile | 90 days | |
Secondary | Rate of major complications between patients with perioperative versus prolonged antibiotic prophylaxis | Major complications is defined by a Clavien-Dindo score of =III.
Clavien-Dindo classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade IIIa: Requiring surgical, endoscopic or radiological intervention not under general anesthesia Grade IIIb: Requiring surgical, endoscopic or radiological intervention under general anesthesia Grade IVa: Life-threatening complication (including CNS complications)* requiring IC/ICU-management with single organ dysfunction (including dialysis). Grade IVb: Life-threatening complication (including CNS complications)* requiring IC/ICU-management with multi organ dysfunction. Grade V: Death of a patient |
90 days | |
Secondary | The number of reinterventions in patients with perioperative versus prolonged antibiotic prophylaxis | Reinterventions could be either radiological, surgical or endoscopic reinterventions | 90 days | |
Secondary | The number of ICU admission in patients with perioperative versus prolonged antibiotic prophylaxis | ICU admission | 90 days | |
Secondary | Length of hospital stay in patients with perioperative versus prolonged antibiotic prophylaxis | In days | 90 days | |
Secondary | The number of readmissions between patients with perioperative versus prolonged antibiotic prophylaxis | Readmission into the hospital | 90 days | |
Secondary | Mortality | In-hospital and 90-days mortality | 90 days |
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