Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
Conditions
Keywords
pancreatoduodenectomy, 17-418, cefoxitin, piperacillin-tazobactam
Brief summary
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
Interventions
DRUGCefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Sponsors
Indiana University
Massachusetts General Hospital
Thomas Jefferson University
Washington University School of Medicine
Advocate Illinois Masonic Medical Center
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
The Cleveland Clinic
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Montefiore Medical Center/Albert Einstein College of Medicine
North Shore University HealthSystem
Milton S. Hershey Medical Center
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre, Canada
Temple University
Ohio State University
The Ottowa Hospital/University of Ottowa
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Providence Health & Services
Albany Medical College
Northwestern University
Universtiy of Mississippi Medical Center
Mount Sinai Hospital, New York
Brody School of Medicine at East Carolina University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years * Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion criteria
* Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD * Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors * Patients who are otherwise ineligible to receive the antibiotics in this study * Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc. * Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) * Patients unable to provide informed consent * Creatinine clearance (CrCl) \</= 40 mL/min * Patients receiving hemodialysis or peritoneal dialysis * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test * Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | 30 days | To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cefoxitin Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | 400 |
| Piperacillin-tazobactam Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | 378 |
| Total | 778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Accrual Closed | 2 | 0 |
| Overall Study | Drug allergy | 0 | 2 |
| Overall Study | Kidney insufficiency | 1 | 0 |
| Overall Study | Operation changed to different resection | 9 | 0 |
| Overall Study | Patient canceled surgery | 5 | 14 |
| Overall Study | Preoperative infection | 10 | 4 |
| Overall Study | Preoperative progression | 14 | 9 |
| Overall Study | Preoperative steroid | 0 | 3 |
| Overall Study | Unresectable at surgery | 39 | 58 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Cefoxitin | Total | Piperacillin-tazobactam |
|---|---|---|---|
| Age, Continuous | 68.0 years | 67.0 years | 66.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 307 Participants | 587 Participants | 280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 87 Participants | 179 Participants | 92 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 46 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 93 Participants | 185 Participants | 92 Participants |
| Race (NIH/OMB) White | 276 Participants | 534 Participants | 258 Participants |
| Region of Enrollment United States | 400 Participants | 778 Participants | 378 Participants |
| Sex: Female, Male Female | 177 Participants | 322 Participants | 145 Participants |
| Sex: Female, Male Male | 223 Participants | 456 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 400 | 5 / 378 |
| other Total, other adverse events | 0 / 400 | 0 / 378 |
| serious Total, serious adverse events | 10 / 400 | 5 / 378 |
Outcome results
Primary
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefoxitin | Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | 400 Participants |
| Piperacillin-tazobactam | Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | 378 Participants |