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Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

This study is investigating how effective a small, uncovered metal tube, called a duodenal stent, is for people who have a blockage in their small intestine (duodenum) caused by cancer. When cancer grows, it can sometimes narrow this part of the digestive system, making it difficult to eat or drink. These stents are placed to open up the blockage and help food pass through. Researchers want to understand how well these stents work over several years and if they remain a good option, or if other treatments like surgery or different endoscopic procedures might be better. The study focuses on people who have had these specific stents placed between 2010 and 2017.

At a glance

Status
Recruiting
Sponsor
Institut Paoli-Calmettes
Enrolment target
200
Start
22 Dec 2017
Estimated completion
01 Dec 2029

What is this study about?

This study is about a medical procedure that helps people who have a blockage in their small intestine. This blockage, called duodenal stenosis, often happens when cancer grows nearby and squashes the tube, making it hard to eat and digest food properly. To fix this, doctors can put in a small, mesh-like metal tube called a duodenal stent. Think of it like a tiny tunnel that holds the narrowed part of the intestine open, allowing food and liquids to pass through more easily.

Since the early 2000s, these stents have become a common way to treat these blockages, especially when surgery to remove the cancer isn't possible. While they often work well at first, sometimes they might need further procedures later on. The doctors running this study want to check how effective these stents are in the long term for people treated in everyday practice. They are particularly interested in how long the stents continue to help people eat and drink comfortably.

By gathering information from many patients who have had these stents, the researchers hope to understand if this treatment remains the best option over time. They are also considering if other treatments, like certain types of surgery or new procedures that create a bypass around the blockage, might be more suitable for some people in the future. This research helps doctors make the best decisions for patients facing these difficult health challenges.

Key takeaways

  • Looks at how well existing small intestine stents (duodenal prostheses) work over time.
  • Focuses on 'uncovered' metal stents used for cancer-related blockages.
  • Aims to improve future treatment decisions for patients with similar conditions.
  • Involves reviewing past medical records, no new procedures or visits required.
  • Participation helps advance medical understanding without any direct physical risks.

Who may be eligible?

To be included in this study, you must have had a blockage in a specific part of your small intestine (called the duodenum) that caused symptoms like difficulty eating or feeling sick. This blockage would have been caused by cancer, and you must have had a specific type of metal tube, called an 'uncovered duodenal prosthesis' (or stent), put in place to help between the years 2010 and 2017.

You would not be able to take part if your blockage was not caused by cancer, for example, if it was due to a non-cancerous condition. Also, if the metal tube you had put in was a 'covered' stent (which is usually used for non-cancerous blockages), you would not be eligible for this study. The study is specifically looking at the 'uncovered' stents used for cancer-related blockages.

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.

  1. Did you have a blockage in your small intestine (duodenum) that caused symptoms?
  2. Was this blockage caused by cancer?
  3. Did you have a small metal tube (an 'uncovered' duodenal stent) put in to help?
  4. Was this stent put in between the years 2010 and 2017?
Answer every question to see your result.

What does participation involve?

This study primarily involves looking back at the medical records of patients who have already received this treatment. This means you wouldn't need to attend extra hospital visits, have additional tests, or take new medication specifically for this study. Researchers will be reviewing existing information about your treatment and how it worked for you over time. The total duration of your participation would involve the research team accessing and analysing your past medical information.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge without having to undergo any new procedures or clinic visits. By reviewing past treatments, doctors can learn more about how well these stents work long-term, which can help improve care for future patients. As the study uses existing medical records, there are no direct physical risks to you. Your personal information will be kept confidential and used anonymously in the study to protect your privacy. You have the right to withdraw your consent for your anonymised data to be used at any time, without affecting your current or future medical care.

Locations (1)

  • Institut Paoli Calmettes
    Verified postcode
    Marseille, France· Recruiting

Common questions

What is a duodenal stent?

It's a small, mesh-like metal tube placed in your small intestine to hold open a blockage, usually caused by cancer, helping food pass through.

Why is this study important?

It helps doctors understand how well these stents work over many years for people with cancer-related blockages, improving future treatments.

Do I need to do anything if I participate?

No, this study looks at past medical records, so you don't need extra appointments or tests.

Will my personal information be kept private?

Yes, all your information will be kept confidential and used anonymously, meaning your name won't be linked to the study findings.

Can I still withdraw from the study?

Yes, you can withdraw your consent for your anonymised data to be used at any time, and it won't affect your medical care.

How to find out more

Fabrice CAILLOL

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the Efficacy of Duodenal Prostheses Not Covere…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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