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 study about?

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.

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 Surgery preparation

The medical team will prepare you for the pancreatoduodenectomy procedure.

You will receive standard pre-surgical care and monitoring.

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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Lcgty Ubpcbbxasobl Mlffvah Cdyrkba (ibtas	Leiden	The Netherlands
Uaxrovyfusnx Mpmacuz Cheerto Gfhvpjabm	Groningen	The Netherlands
Awqnkoiqr Ubb	Amsterdam	The Netherlands
Saiyvnzwj Rzwqxua Unhqgfmjbj Mubcnmp Cfmapl	Nijmegen	The Netherlands
Eeqoogk Ufaomvbuvmrq Mefrcsg Coifxys Rluhduezj (jnczefn Mmk	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.03.2023

Trial locations

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.

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 ID:

2024-510766-16-00

Protocol code:

NL82304.058.22

NCT ID:

NCT05784311

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?