Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy
This study is investigating if an injection of Botox before a specific type of pancreas surgery, called a distal pancreatectomy, can help stop a common problem called a pancreatic fistula. A pancreatic fistula happens when pancreatic fluid leaks after surgery. The study is in its early stages (Phase I and II), meaning it's one of the first times this treatment is being tried in people. The main goal is to check if it's safe to give the Botox injection into a small muscle called the sphincter of Oddi using a camera (endoscope), and to see if it's practical to do this for most patients. They are also looking to see if this injection helps reduce the chance of developing a pancreatic fistula after surgery.
At a glance
What is this study about?
When someone needs surgery on their pancreas, specifically an operation called a distal pancreatectomy, there's a risk of a complication called a pancreatic fistula. This is when digestive juices from the pancreas leak out after the operation, which can cause problems and slow down recovery. Doctors are always looking for ways to make surgery safer and help patients recover better. This study is exploring a new idea to try and prevent this specific complication.
The research looks at using a very small amount of a medicine called Botox, which is well-known for relaxing muscles, to see if it can help. The idea is to inject Botox into a tiny muscle called the sphincter of Oddi, which controls the flow of digestive fluids, before the pancreatic surgery. They do this using a thin, flexible tube with a camera on the end, a procedure called an endoscopy, which allows them to see inside.
This is an early-stage study, meaning it's one of the first times this treatment is being tested in humans. The main goal right now is to ensure the Botox injection itself is safe and that it's practical to do for patients before their surgery. If it proves to be safe and manageable, the next step is to see if it actually helps reduce the chances of developing a pancreatic fistula after surgery. This could potentially make these pancreas operations safer for patients in the future.
Key takeaways
- The study explores using Botox before pancreas surgery to prevent fluid leaks.
- It's an early-stage study (Phase I/II) focusing on safety and practicality.
- The Botox is injected via endoscopy into a specific muscle.
- It aims to make recovery from pancreas surgery potentially smoother.
- Participants must be aged 18 or over and are undergoing a specific pancreas surgery.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. There aren't any upper age limits mentioned, suitable for anyone over 18.
Both men and women are welcome to take part in this study. The study isn't limited by gender, ensuring a broad range of participants. Your overall health status related to needing the specific type of pancreas surgery will be important, but the core eligibility is primarily age and gender-neutral.
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.
- Are you 18 years old or older?
- Are you a man or a woman (all genders are welcome)?
- Are you scheduled to have a specific type of pancreas surgery called a distal pancreatectomy?
- Are you generally well enough to undergo the planned surgery?
What does participation involve?
If you decide to take part in this study, you would first have a healthcare professional check if you meet all the requirements. If you do, you would receive an endoscopy procedure before your main pancreas surgery. During this endoscopy, the Botox medicine would be injected into a specific area. You would then undergo your planned pancreas surgery as normal. Researchers would closely monitor you after your surgery to see if you develop a pancreatic fistula and to check for any side effects relacionadas to the Botox treatment. The exact number of visits and the total duration would depend on your surgical recovery, but you would be regularly assessed during your hospital stay and potentially for a period afterwards.
Potential risks and benefits
Locations (1)
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Common questions
What is a pancreatic fistula?
It's when digestive fluid from the pancreas leaks out after surgery, which can cause problems and slow down recovery.
What is Botox and how is it used here?
Botox is a medicine that relaxes muscles. In this study, a tiny amount is injected into a small muscle near the pancreas to see if it can prevent fluid leaks after surgery.
Is this a new treatment?
Yes, this is an early-stage study, meaning it's one of the first times this specific use of Botox is being tested in people. It's not yet a standard treatment.
Will taking part change my main surgery?
No, your planned pancreas surgery (distal pancreatectomy) would still go ahead as planned. This study adds a step before your surgery.
Who can take part in this study?
Adults aged 18 or over, both men and women, who are going to have a distal pancreatectomy surgery could be eligible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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