Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
When pancreatitis is severe, collections of infected fluid can form around the pancreas, known as 'walled off necrosis'. These often need to be drained and cleared out. Traditionally, this is done using standard endoscopic tools. This study is testing a new device called the EndoRotor, which is designed to remove this fluid more effectively during an endoscopic procedure. Researchers want to see if the EndoRotor works better than current methods by comparing them head-to-head. The goal is to improve treatment for this serious condition, making the procedure safer and more efficient for patients.
At a glance
What is this study about?
This study is looking at a condition called 'walled off necrosis' (WON), which can happen after a severe attack of pancreatitis. Pancreatitis is when the pancreas becomes inflamed, and in some serious cases, infected fluid and dead tissue can collect around it. If these collections last for more than four weeks, they can become encapsulated, forming what doctors call 'walled off necrosis'. This is a serious problem that needs to be treated, often by removing the dead tissue.
Currently, doctors use a step-by-step approach to treat WON. This usually involves draining the fluid, often with the help of an ultrasound, and then using special flexible tubes (endoscopes) and tools passed through the mouth and stomach to directly clear out the dead tissue. While these methods are effective, there's always a search for ways to make these procedures better, safer, and quicker for patients.
This study is comparing these conventional endoscopic methods with a new device called the EndoRotor. The EndoRotor is specifically designed to help clear out this dead tissue more efficiently during the endoscopic procedure. Researchers want to find out if using the EndoRotor is more effective and leads to better outcomes for patients compared to the current standard treatments. It's a randomised controlled trial, which means some patients will receive the EndoRotor treatment, and others will receive the standard treatment, decided by chance, to ensure a fair comparison.
Key takeaways
- This study compares a new device (EndoRotor) to standard treatments for 'walled off necrosis' (WON).
- WON is a collection of infected fluid and dead tissue around the pancreas after severe pancreatitis.
- The goal is to find a more effective way to clear this fluid and tissue using endoscopy.
- Participation involves endoscopic procedures and follow-up to monitor your recovery.
- You will be randomly assigned to either the new device or the standard treatment.
- You can withdraw from the study at any time without affecting your health care.
Who may be eligible?
To be able to take part in this study, you would need to have symptomatic pancreatic necrosis which means you have symptoms from the infected fluid around your pancreas that requires an endoscopic procedure to clear it. Before joining the study, you must have already had an initial drainage procedure where a tube (stent) was placed, and this stent needs to have been in for at least two days.
It's important that you are generally well enough to comfortably undergo repeated endoscopic procedures if needed. You must also be able to understand what the study involves and be willing to give your written consent to participate and attend all follow-up appointments. Your overall health, as assessed by a common medical scale (ASA classification), would need to be below a certain level, generally indicating you are not in a severe health state.
There are also some reasons why you might not be able to join. For example, if you have a significant bleed within the fluid collection, certain blood clotting issues, or if you are pregnant or breastfeeding. Also, if the doctors believe that participating in the study could put your safety at risk, or if you've already had this type of procedure on the current collection, you wouldn't be able to take part. The study is open to both men and women aged 18 and over.
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.
- Do you have symptoms from a fluid collection around your pancreas?
- Have you already had a drainage tube (stent) placed for at least two days?
- Are you generally able to cope with repeat endoscopic procedures if needed?
- Are you 18 years old or older?
- Are you able to provide written consent and attend follow-up appointments?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you join this study, you will either receive treatment with the new EndoRotor device or continue with standard endoscopic methods for clearing the pancreatic fluid collection. The choice of treatment will be decided by chance, like flipping a coin. You will have endoscopic procedures to remove the dead tissue, and the number of procedures will depend on your individual needs. After your treatment, you will have follow-up visits to check your recovery and make sure the treatment has been successful. The specific number of visits and their duration will be explained to you by the study team, but rest assured, they will monitor your progress closely until your condition is stable.
Potential risks and benefits
Locations (12)
- University of Alabama Medical CenterVerified postcodeBirmingham, United States
- California Pacific Medical CenterVerified postcodeSan Francisco, United States
- Thomas Jefferson University HospitalVerified postcodePhiladelphia, United States
- Copenhagen University HospitalVerified postcodeHvidovre, Denmark
- Evangelical HospitalVerified postcodeDüsseldorf, Germany
- University of FrankfurtVerified postcodeFrankfurt, Germany
- Humanitas Reserach Hospital & Humanitas UniversityVerified postcodeMilan, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSVerified postcodeRoma, Italy
- Charlotte van VeldhuisenVerified postcodeAmsterdam, Netherlands
- Amsterdam University Medical CenterVerified postcodeAmsterdam, Netherlands
- St. Antonius HospitalVerified postcodeNieuwegein, Netherlands
- Central Manchester University HospitalVerified postcodeManchester, United Kingdom
Common questions
What is 'walled off necrosis'?
It's a collection of infected fluid and dead tissue around your pancreas that forms after severe pancreatitis, and it's surrounded by a wall.
What is an endoscopy?
An endoscopy is a procedure where a thin, flexible tube with a camera is passed through your mouth and digestive system to see and treat problems inside your body.
What is the EndoRotor System?
It's a new device designed to help doctors more effectively clear out the dead tissue during an endoscopic procedure for walled off necrosis.
Will I know which treatment I'm getting?
No, in a 'randomised' study, the treatment you receive (either EndoRotor or standard care) is chosen by chance to ensure a fair comparison, and often you won't know which one it is.
Can I leave the study if I change my mind?
Yes, you are always free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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