RecruitingOBSERVATIONAL

Freiburg TIPS Registry

The Freiburg TIPS Registry is a study for people in Germany who have severe liver problems, like liver cirrhosis or other conditions causing high blood pressure in the liver, and are going to have a procedure called TIPS (transjugular intrahepatic portosystemic shunt) at the University Medical Center Freiburg. TIPS involves putting in a small tube to help blood flow better through the liver. This study aims to understand how patients' health changes before and for at least a year after the TIPS procedure. Researchers will collect health information and blood samples to learn more about the effects of TIPS and improve care for future patients.

At a glance

Status

Recruiting

Sponsor

University Hospital Freiburg

Enrolment target

2,000

Start

01 Jan 2023

Estimated completion

30 Jun 2034

Liver Cirrhosis Portal Hypertension Non-Cirrhotic Portal Hypertension Budd Chiari Syndrome Portal Vein Thrombosis Portal Systemic Shunt

What is this study about?

Imagine your liver is like a filter for your body, but sometimes, due to certain conditions like liver scarring (cirrhosis) or blood clots, the blood flow through it can get blocked, causing pressure to build up. This is called portal hypertension. To help ease this pressure, doctors can sometimes put in a special small tube called a TIPS (Transjugular Intrahepatic Portosystemic Shunt).

This study, called the Freiburg TIPS Registry, is happening at a hospital in Germany. It's designed to carefully watch and learn from people who are having a TIPS procedure because they have serious liver conditions causing high pressure. The doctors want to see how these patients are doing before the TIPS, and then afterward for at least a year. They're gathering lots of information about their health, blood tests, and how they recover, to better understand how TIPS affects people in the long run.

The main goal is to improve future care. By collecting detailed information on many patients, both from those treated recently and some from the past, the researchers hope to find out what works best, spot any common issues, and ultimately make the TIPS procedure even safer and more effective for others who might need it in the future. It's about learning from experience to help everyone.

Key takeaways

This study helps doctors learn more about the TIPS procedure.
It's for people in Germany having a TIPS for serious liver conditions.
Your health and recovery will be closely monitored for at least a year.
You might be asked to provide extra blood samples.
Participation is voluntary and won't affect your medical care.

Who may be eligible?

This study is for adults generally aged between 18 and 100 years old. You might be able to join if you have a serious liver condition causing high blood pressure in your liver (which doctors call 'portal hypertension'), and your medical team has decided that you need to have a TIPS procedure to help with this condition. Both conditions related to liver scarring (cirrhosis) and those not related to it are included.

There are not many reasons why you couldn't take part once you've agreed. The main one is if you decide you no longer want to be in the study and you want to withdraw your permission. The study needs people who are having a TIPS procedure, so if you're not having that particular treatment, you wouldn't be able to join this study.

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 between 18 and 100 years old?
Do you have a serious liver condition causing high blood pressure in your liver?
Has your doctor decided you need to have a TIPS procedure?
Are you able to attend follow-up visits at the University Medical Center Freiburg in Germany?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to participate the day before your TIPS procedure. The medical team will collect detailed information about your health, including your medical history, any scans you've had, and blood test results. They'll also record details about the TIPS procedure itself.

You'll be asked if you'd like to provide blood samples. Some of these samples will be taken from your arm veins, and some special samples will be taken from the liver and around it during your TIPS procedure. These samples will be stored in a special bank for future research.

After your TIPS procedure, you'll have regular check-ups at the University Medical Center Freiburg. These visits usually happen about 3, 6, and 12 months after your procedure. During these follow-up visits, the team will check how you're doing, collect more health information, and you'll be asked for more blood samples. The total duration of your active participation, including follow-up, will be at least 12 months.

Potential risks and benefits

Taking part in this study means doctors will closely monitor your health, which could help you feel more reassured about your recovery. Your information will also help improve care for future patients. There are no additional medical procedures beyond what you would normally have for your TIPS and follow-up, but providing extra blood samples does involve a small, usual risk like a bruise or slight discomfort. You are free to stop participating in the study at any time without affecting your medical care.

Locations (1)

University Medical Center Freiburg, Department of Medicine II
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is TIPS?

TIPS stands for Transjugular Intrahepatic Portosystemic Shunt. It's a medical procedure where doctors insert a small tube into your liver to help reduce high blood pressure caused by certain liver conditions.

Where is this study taking place?

This study is happening at the University Medical Center Freiburg in Germany.

Do I have to take part if I'm having a TIPS procedure?

No, taking part in any study is completely voluntary. Your medical care will not be affected whether you join or not.

What kind of information will you collect about me?

Researchers will collect details about your health, medical history, scan results, blood tests, and how you recover after your TIPS procedure. They might also ask for blood samples.

How long will I be involved in the study?

You will be followed up for at least 12 months after your TIPS procedure, with several visits during that time.

How to find out more

Dominik Bettinger, MD

dominik.bettinger@uniklinik-freiburg.de 49761270-36870 Official trial record

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