Ongoing Clinical Trials for Pancreatoduodenectomy
This article provides information about 2 ongoing clinical trials investigating ways to prevent complications after pancreatoduodenectomy (Whipple’s procedure), a major surgical procedure involving the pancreas and surrounding organs. The trials are exploring different preventive treatments, including antibiotics and nicotine patches, to reduce the risk of post-surgical infections and digestive complications.
Clinical trial locations
- Germany
- Netherlands
Study of cefuroxime and metronidazole to prevent infections after Whipple’s procedure in patients with high risk of bile contamination
This trial, conducted in the Netherlands, focuses on preventing serious infections in patients undergoing pancreatoduodenectomy, commonly known as Whipple’s procedure. This major surgery removes parts of the pancreas and surrounding organs. The study specifically targets patients at higher risk of infection, particularly those who have had bile drainage before surgery or who have a tumor near the pancreas.
Main inclusion criteria: Participants must be at least 18 years old and scheduled for a planned pancreatoduodenectomy. They must have either previous biliary drainage or an ampullary tumor. Patients must be able to provide informed consent for participation.
Main exclusion criteria: The trial excludes individuals under 18 years old, pregnant or breastfeeding women, and patients with active infection at the time of surgery. Other exclusions include previous pancreatic surgery, known allergy to the study antibiotics, severe immunodeficiency, ongoing immunosuppressive treatment, metastatic disease, life expectancy less than 6 months, severe kidney or liver dysfunction, and uncontrolled diabetes.
Study focus: The primary goal is to evaluate whether giving preventive antibiotics can reduce the occurrence of serious infections after surgery, particularly deep infections in the surgical area. The study will also monitor other complications such as problems with wound healing, bleeding, or delayed stomach emptying.
Investigational drugs: The study uses two antibiotics given through intravenous infusion: metronidazole (with a maximum daily dose of 1500 mg) and cefuroxime (with a maximum daily dose of 4500 mg). These medications are commonly used to prevent and treat infections. The treatment period lasts up to 5 days, and patients are monitored for 90 days after surgery.
Study on Nicotine Patch for Preventing Delayed Gastric Emptying in Patients After Pancreatoduodenectomy
This German trial investigates whether a nicotine patch can help prevent or reduce delayed gastric emptying, a condition where the stomach takes longer than normal to empty its contents after pancreatoduodenectomy. This complication can cause nausea, vomiting, bloating, and difficulty maintaining adequate nutrition.
Main inclusion criteria: Participants must be at least 18 years old and scheduled for pancreatoduodenectomy. They must provide written informed consent to participate. If participants are smokers, they must agree to stop smoking during the study medication application period from Day 1 to Day 7.
Main exclusion criteria: The trial excludes patients who have not undergone pancreatoduodenectomy, those outside the specified age range, and individuals who are part of vulnerable populations who might be at higher risk of harm or exploitation.
Study focus: The study aims to assess whether the nicotine patch can improve recovery by preventing or lessening the symptoms of delayed gastric emptying. Researchers will monitor various factors including the need for a naso-gastric tube (a feeding tube through the nose), the ability to eat solid food, occurrences of vomiting or stomach swelling, and any side effects or complications.
Investigational drug: The treatment being tested is Nicotinell 14 mg / 24-hour patch, which delivers nicotine through the skin. Participants receive either the active nicotine patch or a placebo patch for seven days. The patch is applied once every 24 hours. Neither the participants nor the researchers know who receives the actual treatment or placebo, ensuring unbiased results. Nicotine works by binding to specific receptors in the nervous system, which can influence the movement of the stomach and intestines.
Summary
These two clinical trials represent important efforts to reduce complications following pancreatoduodenectomy, a complex surgical procedure. The trials take different approaches: one focuses on preventing infections using antibiotic therapy in the Netherlands, while the other explores the use of nicotine patches to prevent digestive complications in Germany.
Both studies target specific high-risk patient populations and use randomized, controlled methodologies to ensure reliable results. The antibiotic trial specifically addresses patients with higher infection risk due to prior bile drainage or tumor location, while the nicotine patch study focuses on preventing delayed gastric emptying, a common post-surgical complication.
These trials reflect ongoing efforts to improve outcomes for patients undergoing this major surgery, with potential benefits including reduced hospital stays, fewer complications, and improved quality of life during recovery.
