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DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection.

This study, called DRAGON, is collecting information about a treatment for some types of liver cancer and cancers that have spread to the liver. The treatment is called combined portal and hepatic vein embolization (PVE/HVE). It's a way to encourage the healthy part of the liver to grow larger before surgery. This can make surgery safer and more effective for patients who might not otherwise be able to have it. Hospitals from around the world are sharing their experiences with this technique. The main goal is to understand how well PVE/HVE works, if it's safe, and if certain patient characteristics affect the outcome. This helps doctors learn more about who might benefit most from this specialised treatment.

At a glance

Status
Recruiting
Sponsor
Maastricht University Medical Center
Enrolment target
350
Start
16 Mar 2021
Estimated completion
30 Nov 2032

What is this study about?

This research study, called the DRAGON Registry, is looking at a specific treatment approach for people who have liver cancer or cancer that has spread to their liver (also known as liver metastases). For some people, these cancers are considered 'unresectable' at first, which means they can't be fully removed with surgery because there isn't enough healthy liver left to function properly after the operation.

The treatment being studied is called PVE/HVE (combined portal and hepatic vein embolization). This is a procedure designed to make the healthy part of the liver grow larger. If the healthy liver grows enough, it can then be safe for a surgeon to remove the diseased parts. This registry aims to understand how effective this PVE/HVE treatment is, whether it's safe, and which patients benefit most. By collecting information from many hospitals internationally, doctors can learn more about how to use this technique to help more patients become suitable for life-changing surgery.

This study is important because it brings together information from many different patients who have had this procedure. By looking at all this data, doctors hope to get a clearer picture of how PVE/HVE works in real-world settings. This knowledge can then help improve treatment plans for future patients, making sure they get the best possible care.

Key takeaways

  • The study is about a liver treatment called PVE/HVE.
  • It helps some people with liver cancer or metastases become suitable for surgery.
  • Researchers are collecting existing medical information from patients worldwide.
  • The goal is to understand how well the treatment works and if it's safe.
  • This study doesn't involve new tests or treatments for participants.

Who may be eligible?

This study is gathering information from people who have already undergone a specific liver procedure. To be included, you would need to be 18 years old or older. Both men and women are eligible to have their information included in this registry.

The main requirement is that you have previously received treatment called PVE/HVE (combined portal and hepatic vein embolization), or a very similar type of procedure. This means this isn't a study where you try a new treatment; instead, it's about collecting information on a treatment that has already been given.

Essentially, if you are an adult, male or female, and have had the PVE/HVE procedure for liver cancer or liver metastases, your medical information might be included in this international registry.

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. Have you been diagnosed with liver cancer or cancer that has spread to your liver?
  3. Have you undergone the PVE/HVE procedure (or a similar one) previously?
  4. Are you comfortable with researchers reviewing your anonymous medical records?
Answer every question to see your result.

What does participation involve?

If you are eligible, taking part in this study would involve allowing researchers to look at your medical records. This includes information about your health before, during, and after your PVE/HVE procedure. You wouldn't be asked to undergo any new tests, treatments, or visit the hospital specifically for this study.

The researchers will review details like your initial diagnosis, the results of any scans (like CT or MRI), how the PVE/HVE procedure was carried out, and how well your liver responded. They will also collect information on any complications you might have experienced and your overall health outcomes after the procedure.

Since this is mainly a registry, meaning they are collecting existing information, there are no specific medications to take or appointments to attend just for the study. The total duration of your involvement would depend on how long your medical information is followed up by your hospital, but you would not need to do anything extra.

Potential risks and benefits

The main benefit of participating in this registry is that your information will help doctors learn more about the PVE/HVE procedure, potentially improving treatment for others in the future. Since you are not undergoing any new procedures or tests for this study, there are no direct physical risks to you from your participation. The main risk is related to your privacy, but researchers will take steps to keep your personal information confidential. You always have the right to withdraw your consent for your information to be included at any time, without affecting your medical care.

Locations (31)

  • Rush University Medical Center
    Verified postcode
    Chicago, United States· Recruiting
  • Mayo Clinic
    Verified postcode
    Rochester, United States· Recruiting
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States· Recruiting
  • Monash Medical Centre
    Verified postcode
    Clayton, Australia· Recruiting
  • MedUni Wien
    Verified postcode
    Vienna, Austria· Recruiting
  • Social Center South (Klinik Favoriten)
    Verified postcode
    Vienna, Austria· Recruiting
  • UZ Antwerpen
    Verified postcode
    Edegem, Belgium· Recruiting
  • Erasmus Hospital
    Verified postcode
    Anderlecht, Belgium· Recruiting
  • CHU de Liège
    Verified postcode
    Liège, Belgium· Recruiting
  • UZ Gent
    Verified postcode
    Ghent, Belgium· Recruiting
  • Juravinski Hospital and Cancer Centre
    Verified postcode
    Hamilton, Canada· Recruiting
  • The Ottawa Hospital
    Verified postcode
    Ottawa, Canada· Recruiting

Common questions

What is the DRAGON Registry?

It's a study collecting information from many hospitals about a specific liver treatment called PVE/HVE, for people with liver cancer or cancer that has spread to the liver.

What is PVE/HVE?

It's a procedure that encourages the healthy part of the liver to grow bigger, making it safer to remove diseased parts with surgery.

Who can have their information included in this study?

Adults (18 and over), both men and women, who have already had the PVE/HVE procedure for liver cancer or metastases.

Do I need to do anything extra if I'm in this study?

No, you don't. Researchers will just look at your existing medical records; you won't have new appointments or treatments.

How does this study help patients?

By gathering information from many patients, doctors can learn more about how well PVE/HVE works and for whom, potentially improving future treatments.

How to find out more

Fenna Van der Zijden, Dr.

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 "DRAGON Registry - International Multicenter Registry and Med…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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