Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?
This study wants to see if adding a small cap to the end of a flexible camera (endoscope) can help doctors better treat serious bleeding in the upper digestive system, like the stomach or the first part of the small intestine. Upper digestive bleeding can be very serious, and sometimes it's hard for doctors to find exactly where the bleeding is, even with experience. The cap might help improve the view, making it easier to see hidden areas and treat the bleeding effectively. This could lead to quicker procedures and better outcomes for patients experiencing this type of emergency.
At a glance
What is this study about?
This study is exploring a new way to help doctors treat bleeding in the upper part of the digestive system. This kind of bleeding, often from the stomach or the first part of the small intestine, can be a medical emergency. Doctors typically use a procedure called an endoscopy, where a thin, flexible tube with a camera is passed down the throat, to find and treat the source of the bleeding.
However, finding the exact spot where the bleeding is coming from can be tricky, even for skilled doctors. This is because some areas might be hidden by folds in the stomach or gut lining, or the tube might move around due to breathing or muscle contractions. When it's hard to get a good look, the procedure can take longer, or it might not be possible to stop the bleeding as effectively.
This study is testing if adding a small cap to the end of the endoscope can make a difference. The cap is designed to help gently spread out the folds in the digestive tract, giving doctors a clearer view of places that are usually hard to see. If it works, this could help doctors find and treat hidden bleeding sources more quickly and successfully, potentially improving care for people with this serious condition.
Key takeaways
- This study investigates using a special cap during endoscopy for upper digestive bleeding.
- The cap aims to improve visibility and help doctors find bleeding sources more easily.
- Participation is for adults with significant stomach or intestinal bleeding from ulcers.
- It might lead to quicker and more effective treatment for this serious condition.
- The study takes place at Amiens University Hospital for the endoscopy and follow-up.
Who may be eligible?
To join this study, you need to be an adult, 18 years or older, who is suspected of having significant bleeding in the upper part of your digestive system, shown by symptoms like throwing up blood or having very dark, tar-like stools. Your doctor would also need to have given you a specific score (called a Glasgow Blatchford score) of 8 or higher, which indicates the severity of your bleeding.
Also, your endoscopy procedure (the camera test) and any follow-up care must be planned to happen at Amiens University Hospital. The study is specifically looking at bleeding caused by stomach or duodenal ulcers that need treatment during the endoscopy. You wouldn't be able to join if you have certain other medical conditions, like serious liver disease, or if your bleeding is thought to be from beyond the second part of your small intestine, from swollen veins (varices) in your food pipe or stomach, or from inflammation of your food pipe or certain blood vessel problems.
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?
- Do you have suspected bleeding in your upper gut (like throwing up blood or very dark poo)?
- Is your doctor treating you for a bleeding stomach or gut ulcer?
- Will your endoscopy and care happen at Amiens University Hospital?
- Do you not have certain other conditions like serious liver disease or bleeding from swollen veins?
What does participation involve?
As this study is for patients experiencing acute upper gastrointestinal bleeding, the intervention would occur as part of your standard emergency endoscopy procedure. There are no additional visits beyond what your medical team would already recommend for your condition. The study compares a standard endoscopy with one using a small cap on the endoscope. Your medical team will monitor you as usual after the procedure. The total duration of your participation would be limited to the hospital stay and follow-up care related to your bleeding episode, which would be managed according to standard medical practice.
Potential risks and benefits
Locations (1)
- Centre Hospitalier Universitaire d'AmiensVerified postcodeAmiens, France· Recruiting
Common questions
What is an endoscope?
An endoscope is a thin, flexible tube with a camera and light on the end that doctors use to look inside your body, in this case, your upper digestive system.
What is upper gastrointestinal bleeding?
This is bleeding that happens in the upper part of your digestive system, such as your food pipe (oesophagus), stomach, or the first part of your small intestine (duodenum).
What is the 'cap' being tested?
It's a small, clear cap that fits onto the end of the endoscope. It's designed to help doctors get a clearer view by gently moving aside folds in your digestive tract.
Does taking part mean I get different treatment?
You will receive an endoscopy, which is standard treatment. This study is testing a small addition (the cap) to see if it helps improve the standard procedure.
Will this study cost me anything?
No, there are no costs to you for participating in this research study.
How to find out more
Clara YZET, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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