Not yet recruitingNAINTERVENTIONAL

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

This research is investigating the best timing for removing a small, protective tube called a pancreatic stent. This stent is sometimes placed after a procedure called an ERCP (Endoscopic Retrograde Cholangiopancreatography) to help prevent inflammation of the pancreas, known as pancreatitis. The study aims to find out if taking the stent out shortly after the ERCP (within 10 days) versus leaving it in for a longer period (up to 3 months) changes the chances of problems happening. They will compare how many people experience issues related to the stent or its removal in both groups. The goal is to improve how patients recover and reduce any discomfort or complications after this common medical procedure.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Johann Wolfgang Goethe University Hospital

Enrolment target

358

Start

01 Jan 2026

Estimated completion

01 Jun 2032

Stent Dislodgement ERCP Pancreas Stent Post-ERCP Pancreatitis Prophylactic Pancreatic Stent

What is this study about?

This study is looking into a common situation that can happen after a medical procedure called an ERCP. During an ERCP, doctors sometimes place a small, thin tube, called a pancreatic stent, into your pancreas. This is usually done to help protect your pancreas and reduce the chance of it becoming inflamed (a condition called pancreatitis) after the ERCP procedure. It's like putting a temporary guard in place.

The main aim of this study is to figure out the best time to take this protective stent out. Some patients might have it removed quite soon after the ERCP, while others might have it stay in for a bit longer. The researchers want to compare these two approaches to see which one leads to fewer problems and a smoother recovery for patients. They will be carefully watching for any issues related to the stent itself or when it's removed.

This research is important because it could help doctors decide on the best practice for removing these stents. By understanding the timing that causes the fewest problems, they can make the ERCP procedure even safer and more comfortable for future patients. It's about making sure you get the best possible care and recovery after your treatment.

Key takeaways

This study compares different timings for removing pancreatic stents after an ERCP.
It aims to find out which removal time leads to fewer problems for patients.
Participants will be randomly assigned to either an early or later stent removal group.
The study helps improve future care and safety for patients having ERCPs.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to join this study, you would need to have had a specific type of protective pancreatic stent (5Fr 4cm in size) placed. This stent is used to help prevent problems with your pancreas after a procedure called an ERCP.

You also need to be at least 18 years old. Importantly, you must be able to understand what the study involves and agree to take part by giving your informed consent. This means a doctor or nurse will explain everything to you, and you'll have the chance to ask any questions before making your decision.

There are also some reasons why you wouldn't be able to join. For example, if you have had a very serious type of pancreas inflammation (necrotising post-ERCP pancreatitis), or if you are pregnant or breastfeeding. Also, if you have a specific type of stomach surgery called a Billroth II, you would not be able to participate.

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.

I have had a protective pancreatic stent (5Fr 4cm) placed.
I am 18 years old or older.
I am not pregnant or breastfeeding.
I have not had a very severe type of pancreatitis after an ERCP.
I do not have a Billroth II stomach surgery.

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two groups, like flipping a coin. In one group, the pancreatic stent would be removed relatively soon after your ERCP, usually within 12 hours to 10 days. In the other group, the stent would stay in for a longer time, from 4 weeks up to 3 months. The removal procedure would typically involve another endoscopy (a thin tube with a camera down your throat), but sometimes if the stent has moved out on its own, an endoscopy might not be needed.

Before your stent is removed, the medical team might do some standard tests to check on your health. The study involves keeping track of how you're feeling, if the stent comes out on its own, and how many times you need to come in for follow-up checks. All your information will be safely recorded online. The total duration of your participation would depend on which group you are in, ranging from a few days to potentially three months, until your stent is removed and your recovery is checked.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to medical knowledge, which could improve care for future patients undergoing similar procedures. For you personally, it might involve closer monitoring than usual. However, there are potential risks, such as those associated with the stent staying in longer or with the procedure to remove it, though these are typically minor. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Johann Wolfgang Goethe-Universität Frankfurt am Main
Verified postcode
Frankfurt, Germany

Common questions

What is an ERCP?

ERCP stands for Endoscopic Retrograde Cholangiopancreatography. It's a procedure using a thin, flexible tube with a camera to examine and treat problems in your bile ducts and pancreatic ducts.

What is a pancreatic stent?

It's a small, temporary tube placed in your pancreatic duct after an ERCP to help drain fluids and reduce the risk of inflammation, like pancreatitis.

Will I get to choose when my stent is removed?

No, if you join the study, you'll be randomly put into one of two groups. Each group has a different set time frame for when the stent is removed.

What if the stent falls out by itself?

If the stent comes out on its own before the planned removal, that will be noted by the study team, and you might not need another procedure for its removal.

What does 'informed consent' mean?

It means you've had all the study details explained to you, you understand them, you've had your questions answered, and you freely agree to take part.

How to find out more

Florian Michael, Dr. med.

fmichael@med.uni-frankfurt.de 004915117191302 Official trial record

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