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A trial looking at treatment for fluid around the lung caused by mesothelioma (Meso VATS)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

This trial is looking at 2 procedures called pleurodesis and pleurectomy to see which works best to prevent a build up of fluid around the lung. Mesothelial cells make up the lining that covers the organs in the body - the mesothelium. Cancer of the mesothelium is called mesothelioma.

The most common form of mesothelioma affects the lining around the lungs (the pleura). This is called pleural mesothelioma . Another form of mesothelioma develops in the abdomen. This is rare, and is called peritoneal mesothelioma .

This trial is only for patients who have, or who may have, pleural mesothelioma .

Mesothelioma can cause fluid to collect between the lining of the lung and the lining of the chest wall. This is called a pleural effusion . It causes shortness of breath because the the fluid gets in the way and the lungs cannot expand fully.

Doctors can drain off the fluid to help relieve shortness of breath. But it usually builds up again over time. Sticking the lining of the lung to the chest wall can stop this happening. There are 2 main ways to do this.

One is a procedure called pleurodesis . This is where doctors put talc through a tube into the space between the lungs and the chest wall. The other is an operation to remove the membrane around the lungs (the pleura). This is called a pleurectomy . After either of these procedures, there is no longer a space between the pleura where fluid can collect.

At the moment, most people in the UK will have pleurodesis. Some will have a pleurectomy, but this is a relatively new procedure. Some doctors think a pleurectomy may work better, but they are not sure yet. It is a more difficult procedure then pleurodesis, and likely to have more side effects.

The aim of this trial is to compare pleurodesis and pleurectomy to see which one is better at stopping the fluid building up again. Researchers will also ask patients what they think of the procedure, compare the side effects and the cost.

Recruitment

Start 01/09/2003
End 06/01/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

  • Have a pleural effusion that is (or may be) caused by pleural mesothelioma
  • Are well enough to have a general anaesthetic and surgery
  • Are referred by your doctor to one of the doctors involved in this trial, and are able to travel to one of the participating hospitals for treatment

You cannot enter this trial if you

  • Have had pleurodesis before
  • Do not have a pleural effusion
  • Are not fit enough for surgery

Trial design

This is a randomised trial . It will recruit 196 people into 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Patients who have mesothelioma.

If you are in group 1, you will have pleurodesis. Your doctor may

  • Put the talc into the space between the lungs and the chest wall when you have a thoracoscopy
  • Leave a tube called a chest drain in place after the thoracoscopy and use this to put the talc in later
  • Or, put in another chest drain later on

The chest drain slowly drains off the fluid. This may take a few days. Once the fluid has drained, the doctors will put talc in through the tube. The doctor will then clamp the tube for about an hour, and then unclamp it again. Your chest drain will probably stay in place for a few days afterwards.

If you are in group 2, you will have a video assisted thoracoscopic (VATS) pleurectomy. You will have a tube called a chest drain put in to drain off the fluid between your lungs and chest wall. Then you will have keyhole surgery to remove the pleural membrane. This is sometimes called ‘pleural stripping’. You have this done under a general anaesthetic (GA). Your chest drain will stay in place for up to 10 days afterwards.

Patients who have a pleural effusion that may or may not be caused by mesothelioma.

If you are in group 1, you will have a video assisted thoracoscopic (VATS) biopsy of your pleura. If this shows that you have mesothelioma you will have talc pleurodesis as described above. If the biopsy results show that you don’t have mesothelioma, you won’t go on to have pleurodesis.

If you are in group 2, you will have a VATS biopsy and a pleurectomy, as described above. Having a pleurectomy may be useful for treating pleural effusions caused by medical conditions other than mesothelioma.

All patients who have treatment.

You will fill out a questionnaire before you start the trial, and again after 1, 3, 6 and 12 months. This will ask how you have been feeling and about any side effects you have had. It is called a ‘quality of life questionnaire’.

The research team will also ask if you have seen any other health care professionals (your family doctor or a home care team, for example). This is so they can assess the overall cost of each treatment.

Hospital visits

You will have some tests before you start treatment. These include

You will see the doctors and have more tests at 1, 3, 6 and 12 months after you have treatment.

If you are in group 1 and have pleurodesis, you will be in hospital for a week or so altogether. If you are in group 2 and have VATS pleurectomy, you will be in hospital for up to 2 weeks.

Side effects

Most people who have pleurodesis do not have many side effects. The most common side effects are pain and fever.

The most common side effects of VATS pleurectomy are

  • Infection
  • Bleeding
  • Problems with function of heart or lungs during the operation
  • Pain

There is more information about pleurodesis on CancerHelp UK.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Robert Rintoul

Supported by

BUPA Foundation
National Institute for Health Research Cancer Research Network (NCRN)
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Updated: 25 January 2012