All studies
RecruitingNAINTERVENTIONAL

EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)

This study focuses on a procedure called EDEE, which stands for Endoscopic Ultrasound-Directed Transenteric ERCP. It's designed for people who need help with their bile ducts, especially if traditional methods aren't possible. This can happen due to certain medical conditions, including cancer, or if previous surgery has changed the body's internal plumbing. The study aims to look back at existing cases to understand how successful and safe EDEE has been. It’s a combination of two procedures: first, creating a new pathway using a small, temporary tube (stent), and then performing the main treatment through this new path. This could offer a better solution for patients who currently have limited options.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Evangelisches Krankenhaus Düsseldorf
Enrolment target
40
Start
01 Feb 2020
Estimated completion
01 Jan 2027

What is this study about?

When you have problems with your bile ducts, which help your body digest food, doctors often use a procedure called ERCP. It's a common way to treat issues like blockages. However, for some people, ERCP isn't straightforward. This might be because of conditions like stomach cancer that block the usual path, or if they've had surgery that changed their internal anatomy, making it hard to reach the bile ducts.

In these situations, reaching the bile ducts for treatment can be a real challenge. Current alternatives often have their own difficulties. For example, some approaches involve draining fluid from the outside of the body, which can be uncomfortable and sometimes needs repeated visits. Other special procedures, while helpful, might not be suitable if the problem is complicated or in a hard-to-reach area.

This study is about a newer, combined procedure called EDEE (Endoscopic Ultrasound-Directed Transenteric ERCP). Think of it as creating a temporary, easier route to your bile ducts. First, doctors use ultrasound (sound waves) to guide a special small tube, called a stent, to create a new connection inside your body. Then, through this new connection, they can perform the necessary bile duct treatment. This study is looking back at how well this EDEE approach has worked for patients so far, and how safe it has proven to be. The hope is that EDEE can offer a more effective and less invasive solution for patients who have limited options.

Key takeaways

  • This study explores a new procedure called EDEE for bile duct problems.
  • EDEE is for patients where traditional treatments are difficult or impossible.
  • It combines two steps to create a new path for treatment.
  • The study examines past cases to understand EDEE's safety and success.
  • It aims to improve options for patients with challenging bile duct conditions.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, 18 years old or older. The main requirement is that your doctors believe the EDEE procedure is the right treatment for your specific bile duct issue.

It's important to understand that if you are under 18, this study would not be suitable for you. Also, you would need to agree to take part by signing a consent form, which shows you understand what the study involves.

Essentially, if your medical team thinks EDEE could help your bile duct problem and you meet the age requirement, you'd be a potential candidate for your doctors to review.

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. Are you 18 years old or older?
  2. Has your doctor suggested the EDEE procedure for your bile duct problem?
  3. Are you willing to sign a consent form to allow your data to be used?
  4. Do you have a bile duct issue that needs intervention?
Answer every question to see your result.

What does participation involve?

This study is a bit different because it's a "retrospective study." This means researchers are looking back at the medical records of patients who have already had the EDEE procedure. Therefore, there's no active participation required from you if you're a patient whose data is being reviewed. You wouldn't need to attend extra visits, have additional assessments, take new medication, or have extra follow-up appointments specifically for this study. The researchers are simply gathering and analysing information from your past treatment records.

Potential risks and benefits

Since this is a retrospective study, meaning researchers are looking at past treatments, there are no direct risks or benefits for patients whose information is being reviewed. The EDEE procedure itself, like any medical procedure, carries potential risks such as infection, bleeding, or injury to surrounding organs, and its own benefits, which relate to addressing bile duct issues. The benefit of this specific study is to help doctors learn more about the safety and effectiveness of the EDEE procedure as a treatment option, which could benefit future patients. Patients whose data is being used always have the right to withdraw their consent for their de-identified information to be part of the study, if they had previously agreed.

Locations (1)

  • Evangelisches Krankenhaus Düsseldorf
    Verified postcode
    Düsseldorf, Germany· Recruiting

Common questions

What are bile ducts?

Bile ducts are small tubes in your body that carry a digestive fluid called bile from your liver to your small intestine.

What does 'inaccessible papilla' mean?

The papilla is a small opening where bile ducts connect to the intestine. 'Inaccessible' means doctors can't easily reach it with standard tools.

What is 'altered anatomy'?

This refers to changes in your internal body structure, often due to previous surgery or a medical condition, which can make procedures more difficult.

What is a 'retrospective study'?

It's a study where researchers look back at existing medical records and data that have already been collected, rather than starting new treatments.

Will I have to do anything if my information is used?

No, if your past treatment records are included, you won't need to do anything extra. The researchers will simply review your de-identified data.

How to find out more

Carina Friesl

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 "EUS-directed Transenteric ERCP (EDEE) in Patients With Benig…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.