Laser Ablation versus Mechanochemical Ablation (LAMA) trial
Research type
Research Study
Full title
A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.
IRAS ID
168206
Contact name
Ian Chetter
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Eudract number
2015-000730-30
Research summary
Summary of Research:
Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat.Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort.
Since NICE guidelines, a new treatment known as mechanochemical ablation (MOCA) has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same.
This trial will randomly allocate volunteer patients to have their varicose veins treated with heat or MOCA. We will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results.
Summary of Results:
Varicose veins are a common issue, affecting about one-third of adults in the world, and this number is expected to rise as the population ages. There are a variety of minimally invasive treatment options.Objective: This study compared two treatments for varicose veins: mechanochemical ablation (MOCA) with ambulatory phlebectomy (AP) and endovenous laser ablation (EVLA) with AP. Initially, MOCA showed a lower success rate in closing veins and did not reduce pain compared to EVLA. Both treatments improved patients’ quality of life equally. These are the results after five years.
Methods: 150 patients with varicose veins were randomly assigned to receive either MOCA or EVLA, both with AP. Researchers measured the proportion of veins closed, need for additional treatments, severity of vein disease, and quality of life after five years.
Results:
Follow-up was completed by 76% of MOCA patients and 69% of EVLA patients.
Vein closure was significantly lower in the MOCA group (47%) compared to the EVLA group (92%).
More patients in the MOCA group needed additional treatments (21%) compared to the EVLA group (9%).
There were no significant differences in disease severity or quality of life between the two groups.Conclusion: After five years, MOCA was less effective at closing veins and required more additional treatments compared to EVLA. However, both treatments resulted in similar quality of life improvements.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0207
Date of REC Opinion
21 May 2015
REC opinion
Favourable Opinion