In short
Currently, there is one clinical trial underway for patients with tumours of the ampulla of Vater. This trial is taking place in France and focuses on preventing infections after pancreatic surgery in patients who have had a biliary stent placed before the operation. The study examines the optimal duration of antibiotic treatment following surgery.
Clinical trial locations
Study on Post-Surgery Antibiotic Use for Patients with Biliary Stents Undergoing Pancreaticoduodenectomy: Piperacillin and Tazobactam Evaluation
This clinical trial is designed for patients who are undergoing pancreaticoduodenectomy, a major surgical procedure often performed to treat tumours located near the pancreas, including tumours of the ampulla of Vater. The study focuses specifically on patients who have had a biliary stent placed before surgery to help with bile drainage.
Inclusion criteria: To participate in this trial, patients must have a planned pancreaticoduodenectomy for certain types of tumours near the pancreas. They must have undergone pre-operative biliary drainage using a tube placed either endoscopically or through imaging-guided techniques. Participants must be at least 18 years old, able to follow study requirements, and have social security or national health insurance. Women of childbearing potential must use highly effective birth control methods and have a negative pregnancy test before joining. All participants must provide informed consent after understanding the study details.
Exclusion criteria: The trial excludes patients who are not undergoing pancreaticoduodenectomy. Interestingly, while the trial focuses on patients with biliary stents, the exclusion criteria mention patients with preoperative biliary stents, which appears to relate to specific stent characteristics not detailed in the available information.
Main focus and goal: The primary aim of this study is to compare two different approaches to antibiotic use after surgery. Researchers want to determine whether a 5-day course of antibiotics is more effective than a shorter course in preventing infections at the surgical site. The trial will monitor patients for up to 90 days after surgery, checking for signs of infection and other complications such as pancreatic fistula (an abnormal connection between the pancreas and other organs that causes fluid leakage) or bile leakage (where bile escapes into the abdominal cavity).
Investigational drug: The study uses Piperacillin/Tazobactam, a combination antibiotic medication. Piperacillin works by preventing bacteria from building their protective cell walls, while Tazobactam helps Piperacillin work more effectively by blocking enzymes that some bacteria produce to resist antibiotics. This medication is given through an intravenous infusion (IV drip) and is already well-established in medical practice for treating various bacterial infections in hospital settings.
Throughout the trial, patients receive careful monitoring. After surgery and initial postoperative care, they are administered the antibiotic treatment according to one of the two study approaches. Regular assessments check for any complications, and a comprehensive evaluation takes place 90 days after surgery to assess overall health, any infectious complications, and the presence of bacterial resistance patterns.
Summary
For patients with tumours of the ampulla of Vater, there is currently one active clinical trial available, located in France. This trial addresses an important aspect of surgical care: preventing infections after complex pancreatic surgery in patients who have required biliary drainage before their operation. The study focuses on optimizing antibiotic treatment duration using Piperacillin/Tazobactam, a well-established combination antibiotic. This research may help doctors determine the best approach to reduce the risk of serious post-surgical complications, including infections, pancreatic fistulas, and bile leakage, which can significantly impact recovery and patient outcomes.
