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Study on Post-Surgery Antibiotic Use for Patients with Biliary Stents Undergoing Pancreaticoduodenectomy: Piperacillin and Tazobactam Evaluation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients who have undergone a surgical procedure called pancreaticoduodenectomy, often performed to treat certain types of tumors near the pancreas. These patients have a biliary stent placed before surgery to help with bile drainage. The study is investigating the use of a medication called Piperacillin/Tazobactam, which is a combination of two antibiotics, to prevent infections after surgery.

The purpose of the study is to compare two different ways of using Piperacillin/Tazobactam to see if a 5-day course of antibiotics after surgery is more effective than a shorter course in preventing infections at the surgical site. Participants in the study will receive either the 5-day antibiotic treatment or a shorter course, and their recovery will be monitored to check for any signs of infection.

The study will track the presence of infections and other complications for up to 90 days after surgery. This includes monitoring for any issues like pancreatic fistula or bile leakage, which are potential complications following the surgery. The study aims to provide valuable information on the best approach to prevent infections in patients undergoing this type of surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as planned pancreaticoduodenectomy, preoperative biliary drainage, and age requirements.

    Consent is obtained after understanding the study details.

  2. Step 2

    Surgery and initial care

    Undergo pancreaticoduodenectomy, a surgical procedure for patients with certain neoplasms.

    Receive initial postoperative care to ensure recovery from surgery.

  3. Step 3

    Antibiotic treatment

    Administered Piperacillin/Tazobactam through intravenous infusion.

    The treatment involves two modalities: a 5-day postoperative antibiotic therapy or antibiotic prophylaxis.

    The aim is to prevent surgical site infections.

  4. Step 4

    Monitoring and follow-up

    Monitor for any signs of infection, particularly organ/space surgical site infections.

    Regular assessments are conducted to check for complications such as pancreatic fistula or bile leakage.

  5. Step 5

    Evaluation at 90 days

    Evaluate overall health and any infectious complications at 90 days post-surgery.

    Assess morbidity using specific classification systems and check for any readmissions.

  6. Step 6

    Final assessments

    Conduct final assessments to determine the correlation between postoperative and intraoperative samples.

    Evaluate bacteriological resistance and incidence of fungal contamination.

Who can join the trial?

9 criteria

  • Planned surgery called pancreaticoduodenectomy for certain types of tumors near the pancreas.
  • Pre-operative biliary drainage done through a tube placed endoscopically or using imaging techniques.
  • Must be at least 18 years old.
  • Must be able to follow the study rules, as judged by the study doctor.
  • Must have social security or national health insurance.
  • Must be an adult who has read and understood the study information and signed the consent form.
  • Women who can have children must use highly effective birth control methods and have a negative pregnancy test before joining the study.
  • Women who are permanently unable to have children due to surgeries like removal of the uterus or ovaries.
  • Postmenopausal women, meaning they have not had a menstrual period for 12 months without another medical reason.

Who cannot join the trial?

2 criteria

  • Patients who have a **preoperative biliary stent**. This is a small tube placed in the bile duct before surgery to help with drainage.
  • Patients who are not undergoing a **pancreaticoduodenectomy**. This is a type of surgery where part of the pancreas, the duodenum (the first part of the small intestine), and other nearby tissues are removed.
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Investigated drugs

Piperacillin/Tazobactam is a combination antibiotic used to treat a wide variety of bacterial infections. In this clinical trial, it is being used to prevent or treat infections that may occur after surgery, specifically following a procedure called pancreaticoduodenectomy. The trial aims to determine if a 5-day course of this antibiotic is more effective than a shorter course in preventing surgical site infections in patients who have had a biliary stent placed before surgery.

What is already known about the treatment

Piperacillin/Tazobactam – This medication is administered intravenously, typically through an IV drip, and is used to treat a variety of bacterial infections. It is currently well-established in medical practice and literature as a broad-spectrum antibiotic, often used in hospital settings. The main therapeutic indication for Piperacillin/Tazobactam is to prevent or treat infections, particularly in patients undergoing surgery, such as those with a preoperative biliary stent treated by pancreaticoduodenectomy. At the molecular level, Piperacillin works by inhibiting bacterial cell wall synthesis, while Tazobactam inhibits beta-lactamase enzymes, enhancing Piperacillin's effectiveness. It is classified pharmacologically as a combination of a penicillin antibiotic and a beta-lactamase inhibitor.

Investigated diseases

  • Postoperative Pancreatic Fistula

    This condition occurs when there is an abnormal connection that forms between the pancreas and other organs or tissues after surgery, such as a pancreaticoduodenectomy. It results in the leakage of pancreatic fluid, which can lead to inflammation and infection in the surrounding areas. The fistula may cause abdominal pain, fever, and an increase in drainage from surgical sites. Over time, the body may absorb the fluid, or the fistula may close on its own. However, persistent fistulas can lead to further complications if not managed properly.

  • Bile Leakage

    Bile leakage is a condition where bile escapes from the bile ducts into the abdominal cavity, often following surgical procedures like pancreaticoduodenectomy. This leakage can cause irritation and inflammation of the abdominal lining, leading to symptoms such as abdominal pain, nausea, and fever. If not addressed, the leaked bile can lead to infection and abscess formation. The body may reabsorb small amounts of bile, but larger leaks may require intervention to prevent further complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515181-14-00Protocol code2020/0423/HPEstimated enrolment326 patientsSponsorCentre Hospitalier Universitaire Rouen

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