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TIPS in Patients With Decompensated Liver Cirrhosis

This study is based at Hannover Medical School and focuses on a treatment called TIPS (transjugular intrahepatic portosystemic shunt) for people with decompensated liver cirrhosis, a severe liver condition. Researchers are gathering information from patients who receive TIPS, including clinical details and blood samples. The main goal is to understand how well TIPS works and to find ways to improve the treatment. This includes looking into who benefits most from TIPS, to help doctors choose the best treatment for each patient. By carefully studying this, they hope to make TIPS therapy more effective in the future.

At a glance

Status
Recruiting
Sponsor
Hannover Medical School
Enrolment target
250
Start
29 Aug 2019
Estimated completion
01 Dec 2027

What is this study about?

This study is all about a medical procedure called TIPS, which stands for transjugular intrahepatic portosystemic shunt. This procedure is used to treat a serious liver condition called decompensated liver cirrhosis. When your liver is badly damaged, it can’t work properly, and this can lead to problems like fluid build-up and bleeding.

Doctors at Hannover Medical School are collecting information from patients who have a TIPS procedure. They look at things like how patients are doing before, during, and after the procedure, and they also collect blood samples. The idea is to gather as much information as possible to really understand how TIPS helps people with liver cirrhosis.

By carefully looking at all this information, the researchers hope to make the TIPS treatment even better. They want to figure out exactly which patients will benefit most from TIPS, and how to improve the procedure so it works well for more people. This kind of research helps doctors give the best possible care to patients with liver conditions.

Key takeaways

  • Study aims to improve TIPS treatment for severe liver disease.
  • Researchers collect data and blood samples from routine care.
  • No new treatments or extra procedures are involved.
  • Participation helps future patients with liver cirrhosis.
  • You must be treated at Hannover Medical School.
  • You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to have liver cirrhosis that has become serious (decompensated). Also, your doctors must have decided that you need a TIPS procedure as part of your treatment. You must be receiving your care at the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School.

Before you can join, you’ll also need to understand what the study involves and agree to take part by giving your informed consent. This means signing a form that says you understand and agree.

There are also a few reasons why you wouldn't be able to join. If you are pregnant or breastfeeding, or if you are under 18 years old, you wouldn't be eligible. Also, if you have severe anaemia (low red blood cell count) with a very specific low haemoglobin level, or if you don't wish to give your informed consent, you wouldn't be able to take part.

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. Do you have decompensated liver cirrhosis?
  2. Has your doctor said you need a TIPS procedure?
  3. Are you being treated at Hannover Medical School's Gastroenterology, Hepatology and Endocrinology department?
  4. Are you 18 years old or older?
  5. Are you NOT pregnant or breastfeeding?
  6. Do you NOT have severe anaemia (low blood iron count)?
Answer every question to see your result.

What does participation involve?

This study is a patient registry, which means it collects information about your health and treatment over time. If you take part, your doctors will continue to treat you as they normally would at Hannover Medical School. When you have your TIPS procedure, the research team will collect de-identified clinical information from your medical records. This includes details about your condition, your treatment, and how you are feeling. They will also collect blood samples that are taken during your regular medical care. There are no extra tests or visits specifically for this study. The information and samples collected will help researchers study the TIPS procedure. The total duration of your participation in terms of data collection would be ongoing as long as you are receiving care at the department and wish to be included.

Potential risks and benefits

Since this is a registry study collecting information from your routine care, there are no additional treatments or procedures specific to the study, so you won't face extra risks from the study itself. The potential benefits are for future patients rather than directly for you; by contributing your data, you are helping doctors learn more about TIPS to improve treatment for others with liver cirrhosis. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

  • Hannover Medical School
    Verified postcode
    Hanover, Germany· Recruiting

Common questions

What is decompensated liver cirrhosis?

It's a serious stage of liver damage where the liver can no longer do its job properly, leading to complications like fluid build-up or bleeding.

What is a TIPS procedure?

TIPS stands for transjugular intrahepatic portosystemic shunt. It's a procedure where doctors create a new pathway in the liver to help blood flow better and reduce pressure.

Will I receive new medicine in this study?

No, this study only collects information from your usual medical care and treatment; you won't receive any new medications specifically for the study.

Do I have to live in Hannover to be in this study?

You need to be receiving treatment at the specific medical department at Hannover Medical School to be included in this study.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Benjamin Maasoumy, PD

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 "TIPS in Patients With Decompensated Liver Cirrhosis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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