A Study of Experimental Cefoxitin or Piperacillin-Tazobactam to Prevent Postoperative Infections After Pancreatic Cancer Surgery

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"This study hopes to determine whether Cefoxitin or Piperacillin-Tazobactam prevents postoperative infections better."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: pancreatic cancer, pancreas cancer, pancreatic cancer surgery, pancreas, pancreatic disease
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
We invite you to take part in a research study because you are scheduled to undergo an operation called pancreatoduodenectomy or Whipple procedure.

This operation involves removing four (4) parts of your digestive system.
1. First, it removes a portion of your small intestine, called the duodenum.
2. Second, it removes a portion of your pancreas, an organ that helps with your digestion and blood sugar levels.
3. Third, it removes a portion of your biliary system, called the common bile duct. It drains bile from your gallbladder and your liver into your intestines.
4. Fourth, it also removes your gallbladder, another part of your biliary system.

Once these four parts of your digestive system are removed, your surgeon will reconstruct your digestive system to make sure you are able to eat.

Because your surgeon must make a cut in your skin to perform your operation, there is a risk for an infection (called a surgical site infection). Antibiotics are given approximately one hour prior to your operation to try to prevent these infections.

All patients undergoing this type of surgery will receive antibiotics during their operation. The current guidelines recommend the antibiotic cefoxitin.

This study is a clinical trial, or research experiment. Both cefoxitin and piperacillin-tazobactam are antibiotics that can be used in this way, but it is unknown which one is better.

Cefoxitin is FDA-approved to be used as surgical antibiotic prophylaxis. Piperacillin-tazobactam is not FDA-approved to be used as surgical antibiotic prophylaxis, but it is FDA approved for other purposes. It is often used as surgical antibiotic prophylaxis. Some surgeons think that it is more effective than cefoxitin, which is why we are conducting this study.

In this study, you will get either cefoxitin or piperacillin-tazobactam. Both are antibiotics that you will receive through an IV just before your surgery. Your surgeon and your care team will know which antibiotic you were given during your operation. You may ask which antibiotic you were given if you would like to know. We are hoping that piperacillan will help reduce the rate of infections compared to cefoxitin.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 30 days after your surgery.
Recruitment period
From July 17, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Abimbola Olusanya
Research Topic
Conditions:
  • Pancreatic Cancer
  • Pancreas Cancer
  • Pancreatic Diseases

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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