This phase II trial tests how well extending antibiotics (piperacillin-tazobactam and amoxicillin-clavulanic acid) to prevent (prophylaxis) infection works to prevent complications, such as a clinically relevant postoperative pancreatic fistula (CR-POPF), in patients with intermediate and high-risk fistula risk scores (FRS) after a pancreatoduodenectomy (PD). A PD is a surgical procedure to treat benign or malignant conditions that involve the pancreas and can be complicated by leaking of pancreatic fluid, known as a postoperative pancreatic fistula. A fistula results from a leak at the place that the pancreas is connected to the bowel. This leakage can make patients sick and lead to other complications, like sepsis and bleeding, and may also require another surgery or procedure to correct or control. Antibiotics, such as piperacillin-tazobactam and amoxicillin-clavulanic acid, may prevent or control infections in patients after a PD and may prevent postoperative complications. Extending piperacillin-tazobactam and amoxicillin-clavulanic acid postoperatively may prevent the development of a pancreatic fistula and reduce complications in patients after a PD.
Additional locations may be listed on ClinicalTrials.gov for NCT05753735.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high FRS who undergo PD reduces the rate of CR-POPF in the intervention group, as defined by the International Study Group of Pancreatic Fistula (ISGPF) taskforce guidelines.
SECONDARY OBJECTIVE:
I. To analyze other pertinent postpancreatectomy outcomes between treatment arms.
OUTLINE: Patients receive piperacillin-tazobactam intravenously (IV) over 30 minutes prior to surgical incision and then every 2 hours intra-operatively and undergo pancreaticoduodenectomy and placement of at least 2 drains at time of surgery. Patients then undergo a fistula risk score assessment intraoperatively and those whose fistula risk score is >=3 are randomized to 1 of 2 arms.
ARM I: Patients receive piperacillin-tazobactam IV over 30 minutes every 6 hours following completion of surgery for up to 10 days or until discharge. If discharged prior to day 10, patient will receive amoxicillin-clavulanic acid orally (PO) every 12 hours to complete 10 days total of antibiotics. Patients also undergo removal of drains on or after postoperative day 4 at the discretion of the surgeon.
ARM II: Patients may receive piperacillin-tazobactam IV over 30 minutes every 6 hours up to 24 hours from completion of surgery. Patients also undergo removal of drains on or after postoperative day 4 at the discretion of the surgeon.
Patients follow up for 90 days after surgery or until death, whichever is first.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorLee Mayer Ocuin
