Extract

Background and study aims Varicose veins are a common problem and affect about 30-40% of the population at some point in their lives. The severity of varicose veins varies from purely cosmetic to severe leg ulceration and it has been shown that treating varicose veins results in significant improvements in quality of life. New minimally invasive treatments have become available in the last decade - these are termed endovenous ablation treatments (inside-the-vein closure treatments). These techniques either use energy to heat the inside of the vein, causing it to stick together and block off (ablation). Alternatively, we can use chemicals (glues) to stick the vein together (pharmacological occlusion) or a combination of a mechanical tip and chemicals to stick the vein together and block it off (pharmaco-mechanical ablation). All of these treatments seal off the problem vein. In this trial we are using either radiofrequency heat ablation or pharmaco-mechanical ablation to seal off the vein. Endovenous radiofrequency ablation treatment uses heat energy delivered via a probe inserted into the vein in order to treat the long veins in the leg, and has been shown to be safe and effective. The device is called VNUS ClosureFAST. Pharmacomechanical ablation treatment uses a rotating metal tip to 'scratch' the lining of the vein and inject a liquid chemical called sclerosant into the vein at the same time. The sclerosant causes the vein to stick together. This technique has also been shown to be safe and effective. The device is called ClariVein. The varicosities (or lumpy veins) are removed via small cuts (<0.5 cm long) in the skin termed 'phlebectomies' or 'avulsions', performed at the same time as the long veins are treated. Foam sclerotherapy can be used as an alternative to avulsions. This uses a special chemical made into foam, which is injected into the varicose veins using small needles. As with liquid sclerosant it causes the vein to stick together and block off (sclerose). Who can participate? Any male or female over the age of 18, with symptomatic varicose veins (long or short saphenous veins). What does the study involve? We will ask you about your medical history and fill in a questionnaire with you. You will be assigned a trial number and your treatment plan will be randomly allocated. The allocation will not affect the standard of your care. It will decide the treatment device used. Both are standard care treatment options. You will then have endovenous treatment of your varicose veins with avulsions. The treatment will use either VNUS radiofrequency thermal ablation (heat treatment) or ClariVein pharmacomechanical ablation (mechanical and chemical treatment). This will be carried out under local anaesthetic. You will be asked to score the level of pain experienced during the procedure using a special scale. You will then be asked to keep a patient diary for the 30 days after treatment. 30 days after your treatment you will be reviewed in clinic with a further questionnaire and a repeat venous duplex. Six months after your operation you will again be reviewed in clinic with a venous duplex ultrasound of your leg to assess technical success and another questionnaire. What are the possible benefits and risks of participating? You are not expected to gain any personal benefit from taking part in this study. However, the information gained may help other people in the future. It is not possible to offer any financial incentive for taking part in the study. There are no specific side-effects, disadvantages or risks from taking part in this study as both treatments offered are standard practice. The differing techniques are utilised throughout the world. The specific risks of varicose vein treatment are the same for all treatments - the most common are bleeding, bruising and infection. This is because cuts are made in the skin and the veins, which would be expected to lead to some bleeding, which is controlled at the operation. Cuts in the skin provide a possible route of entry for infection, which is controlled with antibiotics at the operation and further antibiotics if required. The major complication associated with all varicose vein procedures is a deep vein thrombosis (DVT). This is a clot in the deep veins of the leg (famously called ‘economy class syndrome’). This is reduced in the case of endovenous treatment due to reduced to pain post-operatively - patients are often back at work the day after the procedure. Due to the minimally-invasive ('keyhole') technique the risk of serious bleeding is greatly reduced in endovenous treatment and we are able to give a special blood-thinning injection to help reduce the risk of clots in the leg veins. Where is the study run from? Imperial College Healthcare NHS Trust and Imperial College (UK) When is the study starting and how long is it expected to run for? August 2012 to September 2014 Who is funding the study? Vascular Insights (USA) Who is the main contact? Mr Tristan Lane [email protected]

Inclusion criteria

• Varicose veins, venous disease

Links

• ictrp
• isrctn