This phase II/III trial compares the effect octreotide and the duration of antibiotic treatment has on outcomes in patients undergoing a Whipple procedure. A Whipple procedure is a surgery that may remove all or part of the pancreas, part of the intestines, stomach and gallbladder. Leakage from the pancreas due to damaged pancreatic ducts (fistula) is a major complication following pancreatic resection often delaying further treatment and increasing hospital stays. Antibiotics along with octreotide, which works by inhibiting pancreatic secretions, is standard treatment for a pancreatic fistula. This study will determine if the length of antibiotic treatment decreases the rate of fistulas and shortens hospital stays.
Additional locations may be listed on ClinicalTrials.gov for NCT04329039.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
l. To determine the individual treatment effect of somatostatin.
II. To determine whether duration of antibiotic therapy coupled with octreotide provides improved outcomes after pancreaticoduodenectomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo Whipple procedure. Patients given octreotide subcutaneously (SC) for 7 days on study. Patients are also given ceftriaxone intravenously (IV), metronidazole IV, piperacillin-tazobactam IV, and levofloxacin IV intraoperatively and for 24 hours postoperatively on study.
GROUP II: Patients undergo Whipple procedure. Patients given octreotide SC for 7 days on study. Patients are also given ceftriaxone IV, metronidazole IV, piperacillin-tazobactam IV, and levofloxacin IV intraoperatively and for 5 days postoperatively on study.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorMichael L. Kendrick
