RecruitingNAINTERVENTIONAL

Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

This research is investigating a new treatment for severe fluid build-up in the tummy, called refractory ascites, which affects people with liver disease (cirrhosis). This condition often requires frequent visits to the hospital for fluid removal. The study is comparing a small implanted device called Alfapump with the usual treatment of regular fluid drainage. Researchers want to see if the Alfapump improves quality of life more, reduces complications, and is financially beneficial by cutting down on hospital visits. They are also looking at whether the Alfapump is a good option for people who are waiting for a liver transplant as well as those who are not.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

17 Jul 2018

Estimated completion

31 May 2027

Ascites Paracentesis Cirrhosis

What is this study about?

When someone has serious liver disease, especially cirrhosis, they can get a build-up of fluid in their tummy, which doctors call ascites. If this fluid build-up becomes very severe and doesn't respond to usual medicines, it's called refractory ascites. Currently, the main treatment involves regularly draining the fluid out, which means frequent hospital trips and can be quite uncomfortable and tiring for patients. This drainage also doesn't stop the fluid from coming back.

This study is looking at a new device called the Alfapump. It's a small pump that doctors place under the skin during a minor operation. Once inside, it automatically moves the fluid from the tummy into the bladder, so it can then be passed out of the body as urine. The aim of this research is to see if using the Alfapump is a better option than the traditional fluid drainage, both in terms of improving quality of life for patients and potentially saving money by reducing the need for costly hospital visits and dealing with complications.

The researchers will follow patients for one year to compare these two ways of managing fluid build-up. They especially want to understand how each treatment affects people who are waiting for a liver transplant versus those who are not, as their needs might be different. The hope is that the Alfapump could offer a more comfortable and effective way to manage this challenging condition.

Key takeaways

Compares Alfapump to regular fluid drainage for severe fluid build-up (ascites).
Aims to improve quality of life and reduce hospital visits.
Specifically for people with advanced liver disease.
Looks at costs and benefits over one year.
Involves a small implanted device for some participants.
You can discuss with your doctor if this study is right for you.

Who may be eligible?

To join this study, you would typically need to have severe fluid build-up in your tummy (refractory ascites) that has required at least five fluid drainage procedures in the last three months. Doctors would also expect you to live for at least another six months. You shouldn't be suitable for another procedure called a TIPS, or you might have decided against it, or already have a TIPS that isn't working properly. You also need to be part of the social security system in France and give your clear, written permission to take part.

There are also several reasons why you might not be able to join. For example, if you have an infection, or certain types of liver cancer that are being managed palliatively. If your liver disease is extremely advanced (indicated by a high MELD score or Child Pugh C score), or if your kidneys aren't working well enough, you might also not be suitable. Other reasons include recent bleeding in your digestive system, certain brain issues linked to liver disease, or if you can't have general anaesthesia or the pump surgery itself due to other medical conditions like blood clotting problems. You also can't be pregnant, breastfeeding, or taking part in another study at the same time.

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.

Do I have severe fluid build-up that needs draining often?
Have I had at least five fluid drainage procedures in the last three months?
Do doctors expect me to live for at least six more months?
Am I suitable for general anaesthesia and a small operation?
Am I NOT currently pregnant or breastfeeding?
Am I NOT taking part in another medical study right now?

Answer every question to see your result.

What does participation involve?

This study will compare the Alfapump system with the current standard treatment of regular fluid drainage (paracentesis) over a period of one year. If you're in the Alfapump group, you would have a small operation to implant the device under your skin. Regardless of which group you are in, you'll have regular check-ups with the study team to monitor your health, how well the treatment is working, and to identify any complications. These visits will likely involve health assessments, blood tests, and perhaps imaging scans. There will be no specific medication given as part of the study; instead, it focuses on comparing the two types of procedures. The research team will track your progress and quality of life for 12 months after starting the treatment.

Potential risks and benefits

Participating in this study could offer some benefits, such as potentially improving your quality of life by reducing the need for frequent fluid drainage procedures if you receive the Alfapump. The study also helps doctors learn more about better ways to manage severe fluid build-up. However, there are potential risks, especially with the Alfapump group, as it involves a surgical procedure with general anaesthesia, carrying risks like infection or bleeding. There's also the chance the device might not work as hoped, or could cause other issues. For those receiving regular fluid drainage, the risks are similar to routine care, such as discomfort or infection from the procedure. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (10)

Amiens-Picardie University Hospital
Verified postcode
Amiens, France· Recruiting
Chu Angers
Verified postcode
Angers, France· Recruiting
Jean MINJOZ Univesity Hospital
Verified postcode
Besançon, France· Recruiting
Haut-Lévêque Hospital
Verified postcode
Bordeaux, France· Not yet recruiting
Beaujon Hospital
Verified postcode
Clichy, France· Recruiting
Grenoble University Hospital
Verified postcode
Grenoble, France· Recruiting
LA PITIE SALPETRIERE Univesity Hospital
Verified postcode
Paris, France· Recruiting
Chu Poitiers
Verified postcode
Poitiers, France· Not yet recruiting
Chu Pontchaillou
Verified postcode
Rennes, France· Recruiting
Toulouse University Hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is refractory ascites?

It's a severe build-up of fluid in the tummy that doesn't get better with usual medicines for people with liver disease.

What is the Alfapump?

It's a small device put under the skin to automatically move fluid from the tummy to the bladder, so it can be passed out as urine.

Why is this study being done?

It aims to see if the Alfapump is more effective and possibly better value than regular fluid drainage for severe tummy fluid build-up.

How long will the study last?

The study will follow participants for one year to compare the two treatments.

Is surgery involved?

Yes, if you are in the group receiving the Alfapump, you will have a small operation to place the device.

How to find out more

Sandra DAVID-TCHOUDA, MD

sdavidtchouda@chu-grenoble.fr +33 476 76 71 86 Official trial record

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