Laser Ablation Versus Mechanochemical Ablation Trial
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 07/31/2019 |
| Iliyowasilishwa Kwanza: | 11/30/2015 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 12/07/2015 |
| Iliyotumwa Kwanza: | 12/10/2015 |
| Sasisho la Mwisho Liliwasilishwa: | 08/08/2019 |
| Sasisho la Mwisho Lilichapishwa: | 08/12/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 05/31/2015 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 07/31/2018 |
| Tarehe ya Kukamilisha Utafiti: | 07/31/2025 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: EndoVenous Laser Ablation
Device: MechanoChemical Ablation (ClariVein®)
Drug: Lidocaine with 1:200,000 epinephrine solution
Drug: EndoVenous Laser Ablation
Drug: EndoVenous Laser Ablation
Drug: MechanoChemical Ablation (ClariVein®)
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: EndoVenous Laser Ablation 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. | Device: EndoVenous Laser Ablation 1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. The EVLA fibre is introduced into the vein using the Seldinger technique and its tip will be positioned under duplex ultrasound (DUS). Then tumescent anaesthetic, made of a solution of 100ml of 1% Lidocaine with 1:200,000 epinephrine in 900ml of 0.9% Sodium Chloride and buffered to pH 7.4 with 10ml of 8.4% Sodium Bicarbonate, will be infiltrated around the target axial vein under DUS using a spinal needle and a peristaltic pump. Following deployment of appropriate laser safety precautions, the laser energy will be delivered via the fibre. The wavelength used is 1470nm, with NeverTouch Gold-Tip fibre, at 10W power. This laser light energy is converted into heat inducing a permanent, non-thrombotic occlusion. |
| Active Comparator: MechanoChemical Ablation (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. | Device: MechanoChemical Ablation (ClariVein®) 1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. MOCA is performed by a device called ClariVein® (Vascular Insights, UK) 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. The sclerosant will be Sodium Tetradecyl Sulphate (STS), marketed as Fibrovein. Concentration of 1.5% Fibrovein will be used, and maximum of 12ml. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Intra-procedural Pain [Up to end of intervention]
2. Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. [At 1 year]
Hatua za Matokeo ya Sekondari
1. Aberdeen Varicose Vein Questionnaire (AVVQ) [1 week, 6 weeks, 6 months, 1 year]
2. Chronic Venous disease quality of life Questionnaire (CIVIQ-20) [1 week, 6 weeks, 6 months, 1 year]
3. VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym) [1 week, 6 weeks, 6 months, 1 year]
4. Short Form 36 [1 week, 6 weeks, 6 months, 1 year]
5. EuroQol (EQ5D) [1 week, 6 weeks, 6 months, 1 year]
6. Post-procedural Pain [Throughout the first week after the procedure]
7. Analgesia Use [1 week]
8. Bruising visual analogue scale [1 week, 6 weeks, 6 months, 1 year]
9. Satisfactory visual analogue scale [1 week, 6 weeks, 6 months, 1 year]
10. Cosmesis visual analogue scale [1 week, 6 weeks, 6 months, 1 year]
11. Recovery time [1 week, 6 weeks, 6 months, 1 year]
12. Complications [1 week, 6 weeks, 6 months, 1 year]
13. Recurrence of Varicose Veins [1 week, 6 weeks, 6 months, 1 year]
14. Disease Progression [1 week, 6 weeks, 6 months, 1 year]
15. Need for Further Treatment [1 week, 6 weeks, 6 months, 1 year]
