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Study of cefuroxime and metronidazole to prevent infections after Whipple's procedure in patients with high risk of bile contamination

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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 undergoing pancreatoduodenectomy (also known as Whipple's procedure), which is a major surgery to remove parts of the pancreas and surrounding organs. The study specifically looks at patients who have a higher risk of infection due to having had bile drainage before surgery or having a tumor near the pancreas. The purpose is to evaluate whether giving preventive antibiotics can reduce the occurrence of serious infections after surgery.

The study will use two antibiotics: metronidazole and cefuroxime, which are medications commonly used to prevent and treat infections. These medications will be given through an infusion (a drip into the vein). The maximum daily dose of metronidazole will be 1500 mg, and for cefuroxime, it will be 4500 mg. The treatment period will last up to 5 days.

During the study, doctors will monitor patients for signs of infection, particularly focusing on infections that develop deep inside the surgical area. They will also track other complications that might occur after surgery, including problems with wound healing, bleeding, or delayed stomach emptying. The study will help determine the most effective way to prevent infections in patients having this type of surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be assigned to one of two treatment groups for your pancreatoduodenectomy (Whipple's procedure) surgery.

    This assignment happens before the surgical procedure and is based on whether you have had prior bile drainage or have a tumor near the small intestine.

  2. Step 2

    Surgery preparation

    The medical team will prepare you for the pancreatoduodenectomy procedure.

    You will receive standard pre-surgical care and monitoring.

  3. Step 3

    Medication administration

    During your treatment, you may receive two medications through an intravenous infusion:

    - Metronidazole (5 mg/ml solution)

    - Cefuroxime (1500 mg solution)

  4. Step 4

    Post-surgery monitoring

    Your recovery will be monitored for 90 days after surgery.

    The medical team will check for any signs of infection or complications.

    Regular examinations will be performed to ensure proper healing.

  5. Step 5

    Follow-up assessments

    Your recovery progress will be evaluated through:

    - Regular physical examinations

    - Monitoring of the surgical site

    - Assessment of any potential complications

    The monitoring period continues until December 31, 2025.

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must be scheduled for a planned (elective) pancreatoduodenectomy (a surgery to remove part of the pancreas, small intestine, and other nearby organs)
  • Must have either:
    • Previous biliary drainage (a procedure where a tube was placed to drain bile before surgery), or
    • An ampullary tumor (a growth in the area where the bile duct and pancreatic duct meet the small intestine)
    • Can be either male or female
    • Must be able to provide informed consent for participation
    • Must not belong to any vulnerable population groups

Who cannot join the trial?

15 criteria

  • Age under 18 years old
  • Pregnancy or breastfeeding
  • Active infection at the time of surgery
  • Previous pancreatic surgery (surgery on the pancreas)
  • Known allergy to antibiotics used in the study
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • Severe immunodeficiency (weakened immune system)
  • Ongoing treatment with immunosuppressive medications (drugs that lower immune system function)
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Life expectancy less than 6 months
  • History of severe allergic reactions
  • Severe kidney or liver dysfunction
  • Uncontrolled diabetes mellitus (high blood sugar)
  • Mental conditions that could affect ability to follow study procedures
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Investigated drugs

Based on the provided trial information about the SPARROW study, which compares antibiotic treatments in Whipple's procedure, the medications involved are: Antibiotics - These are medicines used to treat or prevent bacterial infections. In this trial, they are being studied in two different approaches: as a standard treatment and as a pre-emptive treatment before surgery. The antibiotics help reduce the risk of infections that can occur after Whipple's procedure, which is a major abdominal surgery. Note: The specific types of antibiotics are not mentioned in the source data, but the trial compares different timing strategies of antibiotic administration to prevent post-surgical infections.

What is already known about the treatment

Based on the provided trial data, there are no specific medications listed to describe. The trial appears to be comparing standard versus pre-emptive antibiotic treatment approaches in pancreatoduodenectomy (Whipple's procedure) patients, but the specific antibiotics are not mentioned in the source data. Without information about the particular medications used in the trial, I cannot provide the requested medication descriptions in the specified format. If you could provide the specific antibiotics or other medications used in this clinical trial, I would be happy to create detailed descriptions following the requested format.

Investigated diseases

  • Organ/Space Surgical Site Infection (OSI)

    A serious infection that develops deep within the surgical site, affecting organs or spaces beneath the incisional area. The infection typically occurs within 90 days after surgery and involves internal tissues or organ spaces that were manipulated during the operation. It can be accompanied by bacterial growth in the affected area and may cause inflammation of surrounding tissues.

  • Postoperative Pancreatic Fistula (POPF)

    A condition where pancreatic fluid leaks from the surgical connection of the pancreas after surgery. The leaking pancreatic fluid can collect in the abdomen, forming a connection (fistula) between the pancreas and other organs or the skin surface. The condition typically develops in the days following pancreatic surgery.

  • Delayed Gastric Emptying

    A condition where food stays in the stomach longer than normal after surgery. The stomach takes longer to empty its contents into the small intestine, leading to feelings of fullness, nausea, and reduced appetite. This condition typically develops in the early post-surgical period.

  • Chyle Leak

    A condition where lymphatic fluid (chyle) leaks into the abdominal cavity after surgery. The milky-white fluid accumulates in areas where lymphatic vessels have been disrupted during the surgical procedure. The leak typically becomes apparent within the first few days after surgery.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510766-16-00Protocol codeNL82304.058.22Estimated enrolment458 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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