RecruitingNAINTERVENTIONAL

Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis

This study is looking at the best way to treat a serious complication of acute pancreatitis, called 'walled-off pancreatic necrosis'. This is when infected fluid pockets form. Doctors usually drain these, but sometimes more treatment is needed to clean out the remaining dead tissue. This research compares two methods: using a standard technique versus a newer device called Endorotor PED®. The study aims to see which method is more effective at clearing these fluid pockets and which offers better value for money. Patients will be randomly assigned to one of the two treatment groups. This is a single-blind study, meaning you won't know which treatment you're getting, but your doctors will.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

20 Jan 2026

Estimated completion

01 Nov 2029

Acute Necrotizing Pancreatitis

What is this study about?

Imagine your pancreas gets very inflamed, a condition called acute pancreatitis. Sometimes, this can become really serious, leading to collections of dead tissue and fluid forming, known as 'walled-off pancreatic necrosis'. These collections can cause serious problems for patients, and doctors often need to remove them. The usual first step is to drain these collections, but often, that's not enough to clear everything out. When more cleaning is needed, doctors use a procedure called 'debridement', where they go in with a camera and special tools to remove the dead tissue.

This study is comparing two different ways to do this debridement. One is the 'conventional' way, using the tools doctors usually rely on. The other uses a newer device called Endorotor PED®. The purpose of this research is to find out if the Endorotor PED® system is better than the conventional methods at clearing these fluid pockets. 'Better' could mean it works more effectively, leads to fewer complications, or helps patients recover faster.

By comparing these two treatments, the researchers also want to understand which one offers the best value for money for the National Health Service (NHS). The results of this study could help doctors decide on the most effective and efficient treatment for patients with this difficult condition in the future, ultimately improving care for people with acute necrotizing pancreatitis.

Key takeaways

This study compares two ways to treat serious pancreatitis complications.
It aims to find out if a new device (Endorotor PED®) is better than standard treatment.
Participation involves being assigned to one of two treatment groups by chance.
It's for adults currently in hospital with acute necrotizing pancreatitis and specific fluid collections.
You have at least 24 hours to decide if you want to take part.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and currently in hospital because of severe acute pancreatitis. You must have those specific fluid collections (walled-off pancreatic necrosis) we talked about earlier, and you need to have already had them drained. The doctors will check your recent CT scans and make sure your general health is stable enough for the study. Importantly, you need to still have symptoms or signs of infection more than 48 hours after your drainage procedure, suggesting that more treatment to clear the collection is needed.

There are also reasons why you wouldn't be able to join. For example, if you haven't had your fluid collection drained yet, or if you've already had a similar procedure to remove dead tissue. If you have a serious illness that means you're not expected to live for at least another year, or if you have a known bleeding disorder, you wouldn't be eligible. Also, if you are pregnant or breastfeeding, legally unable to make decisions for yourself, or already taking part in another medical study involving interventions, you cannot join. Finally, if you or your close family decide you don't want to be involved in research, that's perfectly fine, and you won't be included.

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 currently in hospital for severe pancreatitis?
Have you had drainage for walled-off pancreatic necrosis?
Do you still have symptoms or signs of infection related to this after drainage?
Have you *not* already had a procedure to clean out dead tissue in this situation?
Are you *not* pregnant or breastfeeding, and not involved in another intervention study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be assigned by chance (like flipping a coin) to one of two treatment groups: either you'll receive the standard debridement procedure or the debridement procedure using the Endorotor PED® system. You won't know which treatment you're getting, but your doctors will. Both procedures involve going into your body with special instruments to clean out the fluid collections.

Before you make a decision, you'll have at least 24 hours to think about it and discuss it with family or friends. A doctor involved in the study will talk you through everything and answer any questions you have. They will also collect your formal agreement to participate. Throughout the study, you'll have regular check-ups to monitor your progress and make sure the treatment is working as expected. The total duration of your participation will depend on your recovery and how many procedures are needed, but the follow-up will continue for a period to assess the long-term results.

Potential risks and benefits

Taking part in this study means you might receive a new treatment that could potentially be more effective than standard methods, which could lead to a better recovery from your severe pancreatitis. However, as with any medical procedure, there are potential risks, including infection, bleeding, or injury to nearby organs. The study will closely monitor you for any side effects. Remember, joining is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hospital Beaujon, APHP
Verified postcode
Clichy, France· Recruiting

Common questions

What is 'acute necrotizing pancreatitis'?

It's a very serious type of inflammation of your pancreas where some of the tissue can die and cause infected fluid pockets.

What is 'walled-off pancreatic necrosis'?

This is when those pockets of dead tissue and fluid become surrounded by a wall, making them distinct from healthy tissue.

What does 'debridement' mean in this study?

It's a procedure where doctors use special tools to clean out the dead tissue and fluid from these collections inside your body.

Will I know which treatment I'm getting?

No, this is a 'single-blind' study, meaning you won't know if you're getting the standard treatment or the one with the Endorotor PED®.

Can I change my mind about participating?

Yes, absolutely. You can decide to leave the study at any time, and this will not affect your medical care.

How to find out more

Frederic Prat, MD PHD

frederic.prat@aphp.fr 01 40 87 56 63 Official trial record

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