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Not yet recruitingPHASE3INTERVENTIONAL

Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent

This research is looking into the best way to use antibiotics after a big operation on the pancreas and surrounding areas called a pancreaticoduodenectomy, sometimes known as a Whipple procedure. This surgery is complex, and infections can be a common issue afterwards, particularly for patients who had a small tube (stent) placed in their bile duct before the operation. The study aims to compare two different ways of giving a specific broad-spectrum antibiotic (Piperacillin-Tazobactam): either a single dose given just before surgery to prevent infection, or a 5-day course of antibiotics given after the surgery. The main goal is to see if taking antibiotics for 5 days after the operation is better at stopping wound infections and other infection-related problems compared to just the single dose.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
University Hospital, Rouen
Enrolment target
326
Start
01 Jul 2026
Estimated completion
01 Sep 2028

What is this study about?

This study is about making a big operation called a pancreaticoduodenectomy (often called a Whipple procedure) safer and more effective. This surgery treats conditions around the pancreas, like certain cancers. It's a very complicated operation, and unfortunately, patients can sometimes get infections afterwards. These infections can make recovery harder and sometimes lead to serious problems.

One common reason for infections after this surgery is if a patient had a small tube, called a stent, placed in their bile duct before the operation. This stent helps with drainage but can also introduce germs into the bile. These germs can then increase the risk of infection during or after the surgery. Doctors already use antibiotics to try and prevent infections, but they're still working out the best way to give them.

This research is comparing two different ways of using a strong antibiotic called Piperacillin-Tazobactam. One group of patients will receive a single dose of this antibiotic just before surgery, called 'antibiotic prophylaxis,' which is a standard way to prevent infections during operations. Another group will receive the same antibiotic for 5 days after their surgery. The main aim is to find out if taking antibiotics for 5 days after the operation is better at stopping infections, especially around the surgical site, compared to just the single dose given before.

Key takeaways

  • The study aims to improve recovery after complex pancreatic surgery.
  • It compares two ways of giving antibiotics to prevent infections.
  • Patients with a pre-surgery bile duct stent are a key focus.
  • The goal is to see if 5 days of antibiotics are better than a single dose.
  • Participation involves no extra tests beyond standard care.
  • The study focuses on common infection-preventing antibiotics.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and planning to have a pancreaticoduodenectomy operation for growths around the pancreas. You must also have had a tube (stent) placed in your bile duct before your surgery.

There are also some important things that would mean you couldn't join. For example, if you are allergic to certain antibiotics (like penicillin-type drugs), or if you have some serious heart problems that aren't well controlled. Lastly, if you are expecting a different type of pancreas surgery or haven't had a bile duct drainage procedure, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you scheduled for a pancreaticoduodenectomy (Whipple procedure)?
  3. Did you have a bile duct stent placed before your surgery?
  4. Are you able to provide consent and follow medical advice?
  5. Are you NOT allergic to penicillin-type antibiotics?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first receive information and need to sign a consent form. While you are in the hospital for your surgery, you would either receive a single dose of the study antibiotic (Piperacillin-Tazobactam) just before your operation, or you would receive this antibiotic for 5 days after your operation. The doctors will decide which group you are in randomly, like flipping a coin. The study will mainly involve doctors collecting information from your standard hospital care, such as your recovery and whether you get any infections. There won't be extra visits or tests beyond what you would normally have for this type of surgery and recovery. The study focuses on monitoring your health journey after surgery.

Potential risks and benefits

Participating in this study might offer a potential benefit if the 5-day antibiotic treatment proves more effective at preventing infections, which could lead to a smoother recovery. However, there are potential risks associated with any medication, including antibiotics, such as side effects (though the study drug is widely used and well-understood) or allergic reactions. It's important to know that you can choose to leave the study at any time without affecting your medical care. Your doctors will discuss all potential risks and benefits with you in detail.

Locations (1)

  • CHU de ROUEN
    Verified postcode
    Rouen, France

Common questions

What is a pancreaticoduodenectomy?

It's a major surgery that removes part of your pancreas, small intestine, gallbladder, and bile duct, usually to treat certain cancers or other conditions.

Why do some patients need a stent in their bile duct before surgery?

A stent is a small tube placed to help drain bile, which can get blocked, particularly if there's a growth. This helps prepare you for surgery.

What kind of infections are you trying to prevent?

Mainly infections at the surgery site (wound infections) and other infections that can happen after complex operations.

Will I know if I'm getting the 5-day antibiotic or the single dose?

No, you won't know which treatment you receive. This helps ensure the study results are fair and unbiased.

What are broad-spectrum antibiotics?

These are antibiotics that can kill a wide range of different types of bacteria, making them useful for various infections.

How to find out more

Lilian Schwarz

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Postoperative Anti-infective Strategy Following Pancreaticod…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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