Biodegradable Stents in Primary Sclerosing Cholangitis
This study is for people in the UK with a liver condition called Primary Sclerosing Cholangitis (PSC) who have narrowed bile ducts. These narrowings, called strictures, can cause problems. Doctors sometimes widen these ducts using a balloon. This study explores a new option: a special dissolvable tube, called a biodegradable stent, which is placed inside the narrowed duct. The main goal is to see if these stents work well and are safe, especially for ducts that are very narrow. Researchers want to find out if these stents can help reduce how often people need procedures and improve their symptoms and quality of life compared to just using a balloon to widen the ducts. It's hoped this new treatment might offer a better way to manage PSC.
At a glance
What is this study about?
This study is investigating a new treatment for a liver condition called Primary Sclerosing Cholangitis, or PSC. In PSC, the bile ducts – which are small tubes that carry digestive fluid from your liver – can become narrow and blocked. These narrowings are called 'strictures'. When this happens, it can cause problems and affect how well your liver works.
Currently, doctors often try to widen these narrowed ducts using a small balloon during a procedure called an ERCP. For ducts that are very stubbornly narrow, they sometimes place a small plastic tube, called a stent, to keep it open. However, these plastic stents can sometimes lead to issues like inflammation of the pancreas (pancreatitis) or bile duct infections.
This study is looking at a new type of tube called a 'biodegradable stent'. Biodegradable means it gradually dissolves over time, so it wouldn't need to be removed. The researchers want to see if placing these dissolvable stents in very narrow bile ducts can help them to open up and stay open more effectively than traditional methods. They also want to check if these new stents are safe and if they can reduce the number of times people need to have procedures to keep their bile ducts clear. Ultimately, the aim is to find a better, safer way to manage PSC and improve the lives of those with the condition.
Key takeaways
- This study is testing a new dissolvable stent for PSC.
- It aims to reduce repeated procedures for narrowed bile ducts.
- Participation involves an ERCP procedure and follow-up for 12 months.
- Researchers will check if the stents are safe and effective.
- The goal is to improve symptoms and quality of life for PSC patients.
Who may be eligible?
This study is looking for people with Primary Sclerosing Cholangitis (PSC) who have a particularly narrow bile duct (what doctors call a 'high-grade stricture').
There are several reasons why someone might not be able to join. For example, if you've already had a stent or a balloon procedure on your bile ducts in the last four months, or if you currently have a serious bile duct infection, you won't be able to take part. Also, if you’re pregnant, have certain other serious health conditions like HIV or hepatitis, or if your liver disease is very advanced, you wouldn't be eligible.
It’s also important that you can understand what the study involves and agree to take part. The researchers will check for other specific conditions, like signs that a different serious liver problem might be present or certain blood test results, to make sure the study is safe and suitable for everyone involved.
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 Primary Sclerosing Cholangitis (PSC) with a very narrow bile duct?
- Have you had any stent or balloon procedures on your bile ducts in the last 4 months?
- Do you have an active bile duct infection (cholangitis)?
- Are you pregnant or might you be?
- Do you have other serious health conditions like HIV or advanced liver disease?
- Are you able to understand and agree to take part in the study?
What does participation involve?
If you decide to take part in this study, you would have a procedure called an ERCP. During this procedure, a doctor would place a special dissolvable tube (a biodegradable stent) into the narrowed bile duct. The main aim is to see how well these stents work and if they are safe.
After the procedure, you will have several follow-up appointments over 12 months. These appointments will involve checking your symptoms, having blood tests to look at your liver function, and completing questionnaires about your general health and how your symptoms are affecting you. The team will also monitor for any potential side effects or complications. While participating, you would continue to be monitored by your regular doctors, and the study team would work closely with them. The total duration of active participation and follow-up in the study would be 12 months.
Potential risks and benefits
Locations (1)
- King's College Hospital, LondonVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is Primary Sclerosing Cholangitis (PSC)?
PSC is a long-term liver disease where the bile ducts (tubes that carry digestive liquid) become inflamed and scarred, eventually narrowing and blocking them.
What is a 'biodegradable stent'?
It's a special tube that can be placed inside a narrowed bile duct to hold it open. 'Biodegradable' means it will slowly break down and dissolve in the body over time, so it won't need to be removed.
What is an ERCP procedure?
ERCP stands for Endoscopic Retrograde Cholangiopancreatography. It's a procedure where a doctor uses a thin, flexible tube with a camera to look at your bile ducts and carry out treatments, like placing a stent.
Will I have to pay to be part of the study?
No, you will not have to pay for any part of the study treatment or assessments. All costs are covered by the research study.
What if I change my mind about participating?
You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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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