The purpose of this clinical trial is to investigate if prolonged antibiotics after pancreatoduodenectomy can prevent the development of a pancreatic fistula and related complications. Participants who are at high risk of pancreatic fistula will be administered an extended course of antibiotics. While inpatient, the patient will receive these antibiotics through the vein, and after discharge, the antibiotics will be taken by mouth.
Pancreatoduodenectomy (PD) is a commonly performed surgical procedure utilized in the treatment of either localized malignancies or benign conditions that involve the pancreatic head, 2nd/3rd portions of the duodenum, ampulla of Vater, and distal biliary system. Historically, there has been little improvement in the rate of postoperative pancreatic fistula (POPF), which occurs in approximately 10-40% of patients, and is influenced by a number of factors, including surgeon experience, pancreatic gland texture, pancreatic duct size, and underlying diagnosis. POPF is the leaking of enterically contaminated and amylase-rich fluid from the pancreatic-jejunal anastomosis created during PD. This leak may lead to serious complications. The concept of antibiotic mitigation prior to development of a CR-POPF in patients at higher risk of developing CR-POPF is an option that will be explored in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Clinically Relevant (Grade B/C) Postoperative Pancreatic Fistula Rate
To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high fistula risk score who undergo PD reduces the rate of clinically relevant postoperative pancreatic fistula in the intervention group.
Time frame: 56 days
Mortality
Rate of mortality
Time frame: At 30 days
Mortality
Rate of mortality
Time frame: At 90 days
Index Postoperative Length of Stay
Index postoperative length of stay
Time frame: At 90 days
Composite Length of Stay
Composite 90-day length of stay
Time frame: At 90 days
Readmission
Rate of readmission
Time frame: At 30 days
Readmission
Rate of readmission
Time frame: At 90 days
Delayed Gastric Emptying
Rate of delayed gastric emptying
Time frame: At 90 days
Image-guided Drain Placement
Rate of image-guided drain placement
Time frame: At 90 days
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Postpancreatectomy Hemorrhage
Presence of postpancreatectomy hemorrhage
Time frame: At 90 days
Superficial Surgical Site Infection
Presence of superficial surgical site infection
Time frame: At 90 days
Deep Surgical Site Infections
Presence of deep surgical site infections
Time frame: At 90 days
Deep Space Infections/Intra-abdominal Abscess
Presence of deep space infections/intra-abdominal abscess
Time frame: At 90 days
Additional Drain Placement
Rate of additional drain placement
Time frame: At 90 days
Unplanned Return to Operating Room
Measuring occurrences of unplanned return to operating room
Time frame: At 90 days
Acute Kidney Injury
Rate of the presence of acute kidney injury
Time frame: At 90 days
C. Difficile Colitis
Rate of the presence of C. difficile colitis
Time frame: At 90 days