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LAMA Trial to examine EVLA vs MOCA with ClariVein

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A new trial will compare endovenous laser ablation (EVLA) to mechanochemical ablation (MOCA) with ClariVein (Vascular Insights) for treating Superficial venous insufficiency (SVI). The Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA.

Although endovenous thermal techniques, such as EVLA are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as MOCA have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. According to the trial investigators, preliminary experiences with MOCA showed good results and less post-procedural pain.

The paper, ‘Endovenous laser ablation versus mechanochemical ablation with ClariVein in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial’, describing the trial design and outline has been published in the journal Trials. The researchers expect to complete recruitment by 2018.

MOCA is a newer treatment aiming to match the efficacy of thermal ablation whilst using a gentle sclerotherapy technique, with no requirement for TA. A catheter placed within the vein deploys a rotating hollow wire which causes physical damage to the endothelium and the vein goes into spasm. At the same time, a sclerosing agent is injected through the hollow wire into the vein, which results in protein denaturation, endothelial destruction and endoluminal fibrosis. Since no heat is involved and TA is made redundant, thermal-related complications such as pain, haematoma, induration and nerve injury could be reduced.

All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at one year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.

This is a phase IV randomised clinical trial in the setting of a University Teaching Hospital, based in United Kingdom, offering tertiary vascular surgery services. The inclusion criteria are: aged 18 or over; primary symptomatic SVI; reflux greater than 0.5 seconds in the saphenous veins; clinical grades C2 to C6; proposed treatment lengths of at least 10cm; treatment with either EVLA or MOCA is technically feasible; and written informed consent.

The joint primary outcomes will assess the hypothesised advantages and disadvantages of MOCA when compared with EVLA. The first will be patient-reported intra-procedural pain measured on a standardised 100-mm visual analogue scale (VAS). The second will be technical efficacy at 1 year, with successful procedure defined as complete occlusion of the target vein segment. This will be assessed using duplex ultrasound.

The secondary outcomes are procedure time, post-procedural pain, analgesia use, clinical severity, generic and disease-specific quality of life (QoL), bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA.

“The aim of the present randomised clinical trial is twofold. The first hypothesis is that MOCA may cause less initial pain and disability, allowing a more acceptable treatment with an enhanced recovery,” the researchers write. “The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term QoL, increasing the requirement for secondary procedures. In conclusion, the LAMA trial is a randomised controlled trial that aims for reduction in intra- and post-procedural pain after MOCA compared with EVLA, with a similar clinical success and technical efficacy.”

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