Laser Ablation Versus Mechanochemical Ablation Trial
- Conditions
- Varicose Veins
- Interventions
- Registration Number
- NCT02627846
- Lead Sponsor
- Hull University Teaching Hospitals NHS Trust
- Brief Summary
A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.
- Detailed Description
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 such as endovenous laser ablation (EVLA) 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 technique known as mechanochemical ablation (MOCA) using ClariVein® 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 technique 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 either EVLA or MOCA. The investigators 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. Long term follow-ups will occur at 5 and 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Aged 18 or over
- Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
- Clinical grades C2-C6 on the CEAP system
- Superficial axial incompetence with proposed treatment lengths of at least 10cm
- Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
- Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language
- One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
- Unwilling or inability to comply with the requirements for follow-up visits
- Known allergy to medications or dressings used in the treatment
- Known right to left circulatory shunt
- Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
- Pelvic vein insufficiency
- Active or recent thrombophlebitis (within 6 weeks)
- Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
- Pregnancy or breast feeding
- Active malignancy
- Immobility
- Involvement in other CTIMP trials within the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EndoVenous Laser Ablation EVLA EndoVenous Laser Ablation (EVLA) involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion. MechanoChemical Ablation (ClariVein®) ClariVein® Mechanochemical ablation (MOCA) is performed by a device called ClariVein® which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. EndoVenous Laser Ablation Sodium Bicarbonate EndoVenous Laser Ablation (EVLA) involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion. MechanoChemical Ablation (ClariVein®) Sodium Tetradecyl Sulphate Mechanochemical ablation (MOCA) is performed by a device called ClariVein® which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip.
- Primary Outcome Measures
Name Time Method Intra-procedural Pain Up to end of intervention Patient is asked immediately after the procedure of their level of pain experienced during the intervention; measured on a standardised visual analogue scale (VAS).
Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. At 1 year
- Secondary Outcome Measures
Name Time Method Aberdeen Varicose Vein Questionnaire (AVVQ) 1 week, 6 weeks, 6 months, 1 year Disease Specific quality of life
VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym) 1 week, 6 weeks, 6 months, 1 year Disease Specific quality of life
Post-procedural Pain Throughout the first week after the procedure One week pain diary
Bruising visual analogue scale 1 week, 6 weeks, 6 months, 1 year Appreciation of the severity of bruising
Cosmesis visual analogue scale 1 week, 6 weeks, 6 months, 1 year Satisfaction with cosmetic result from treatment
Recovery time 1 week, 6 weeks, 6 months, 1 year Time taken to return to work (if employed) and daily activity
Recurrence of Varicose Veins 1 week, 6 weeks, 6 months, 1 year Combination of history taking, clinical examination and duplex ultrasound assessment.
Chronic Venous disease quality of life Questionnaire (CIVIQ-20) 1 week, 6 weeks, 6 months, 1 year Disease Specific quality of life
Satisfactory visual analogue scale 1 week, 6 weeks, 6 months, 1 year Satisfaction with treatment
Complications 1 week, 6 weeks, 6 months, 1 year Any numbness, persistent bruising, tenderness, skin loss/ulceration, lumpiness, development of thread, skin staining, wound infection, deep vein thrombosis, pulmonary embolus, stroke, loss of vision, damage to major artery, vein or nerve.
Need for Further Treatment 1 week, 6 weeks, 6 months, 1 year Comparison of clinical and duplex ultrasound findings between follow-ups is made and should there be failure of intervention or recurrence of varicose veins, there would be consultation between surgeon and patient to decide whether further intervention is required.
Disease Progression 1 week, 6 weeks, 6 months, 1 year Comparison of clinical and duplex ultrasound findings between follow-ups.
Short Form 36 1 week, 6 weeks, 6 months, 1 year Generic quality of life
EuroQol (EQ5D) 1 week, 6 weeks, 6 months, 1 year Generic quality of life
Analgesia Use 1 week One week analgesia diary
Trial Locations
- Locations (1)
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, United Kingdom