Antibiotics for Preventing Infections After Pancreatic Surgery

Phase 3

Waitlist Available

Led By Michael D'Angelica, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 18 years

Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication

Must not have

Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD

Creatinine clearance (CrCl) </= 40 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two different antibiotics to see which one is better at preventing surgical site infections after pancreatoduodenectomy.

Who is the study for?

Adults (18+) scheduled for pancreatoduodenectomy can join this trial. It's not for pregnant/nursing women, those with allergies to penicillins/cephalosporins, patients on long-term steroids or dialysis, anyone with a recent infection or antibiotic use, and those unlikely to need the surgery per their surgeon.

What is being tested?

The study is testing whether Cefoxitin or Piperacillin-Tazobactam antibiotics are more effective in preventing infections after pancreatoduodenectomy—a surgical procedure involving the removal of part of the pancreas.

What are the potential side effects?

Possible side effects include allergic reactions, gastrointestinal issues like nausea and diarrhea, potential kidney damage especially if there's pre-existing kidney disease, and increased risk of fungal or other non-bacterial infections due to changes in body flora.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a surgery to remove part of my pancreas and small intestine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having or had a minimally invasive surgery for pancreatic disease.

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My kidney function is low, with a creatinine clearance of 40 mL/min or less.

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I am currently on dialysis.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy