Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial

Clement C M Leung, Daniel Carradice, Tom Wallace, Ian C Chetter, Clement C M Leung, Daniel Carradice, Tom Wallace, Ian C Chetter

Abstract

Background: Endovenous thermal techniques, such as endovenous laser ablation (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 mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.

Methods/design: 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. 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 1 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.

Discussion: The aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.

Trial registration: ClinicalTrials.gov identifier: NCT02627846 , registered 8 December 2015 EudraCT number: 2015-000730-30 REC ref: 15/YH/0207 R&D ref: R1788.

Keywords: ClariVein®; EVLA; Endovenous laser ablation; MOCA; Mechanochemical ablation; Outcome; Superficial venous insufficiency; Therapy; Treatment; Varicose vein.

Figures

Fig. 1
Fig. 1
Study flow chart. The total target sample size is 140, which will be randomised to endovenous laser ablation (n = 70) or mechanochemical ablation (n = 70)

References

    1. Evans CJ, Fowkes FGR, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh vein study. J Epidemiol Community Health. 1999;53:149–53. doi: 10.1136/jech.53.3.149.
    1. Shepherd AC, Gohel MS, Lim CS, Davies AH. A study to compare disease-specific quality of life with clinical anatomical and hemodynamic assessments in patients with varicose veins. J Vasc Surg. 2011;53:374–82. doi: 10.1016/j.jvs.2010.09.022.
    1. Van den Oever R, Hepp B, Debbaut B, Simon I. Socio-economic impact of chronic venous insufficiency. An underestimated public health problem. Int Angiol. 1998;17:161–7.
    1. National Institute for Health and Care Excellence. Varicose veins in the legs: the diagnosis and management of varicose veins. Clinical guideline 168. 2013. . Accessed 28 Apr 2016.
    1. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW, Society for Vascular Surgery, American Venous Forum The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53:2S–48. doi: 10.1016/j.jvs.2011.01.079.
    1. Brittenden J, Cotton SC, Elders A, Ramsay CR, Norrie J, Burr J, Campbell B, Bachoo P, Chetter I, Gough M, Earnshaw J, Lees T, Scott J, Baker SA, Francis J, Tassie E, Scotland G, Wileman S, Campbell MK. A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014;371:1218–27. doi: 10.1056/NEJMoa1400781.
    1. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011;98:1117–23. doi: 10.1002/bjs.7615.
    1. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011;98:501–10. doi: 10.1002/bjs.7394.
    1. Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013;257:419–26. doi: 10.1097/SLA.0b013e318275f4e4.
    1. Nandhra S, El-Sheikha J, Carradice D, Wallace T, Souroullas P, Samuel N, Smith G, Chetter IC. A randomised clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. J Vasc Surg. 2015;61:741–6. doi: 10.1016/j.jvs.2014.09.037.
    1. Rasmussen LH, Lawaetz M, Bjoem L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98:1079–87. doi: 10.1002/bjs.7555.
    1. Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS Closure FAST radiofrequency ablation versus laser for varicose veins. Br J Surg. 2010;97:810–8. doi: 10.1002/bjs.7091.
    1. Kendler M, Averbeck M, Simon JC, Ziemer M. Histology of saphenous veins after treatment with the ClariVein® device – an ex-vivo experiment. J Dtsch Dermatol Ges. 2013;11:348–52.
    1. van Eekeren RR, Hillebrands JL, van der Sloot K, de Vries JP, Zeebregts CJ, Reijnen MM. Histological observations one year after mechanochemical endovenous ablation of the great saphenous vein. J Endovasc Ther. 2014;21:429–33. doi: 10.1583/13-4588MR.1.
    1. Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27:67–72. doi: 10.1258/phleb.2011.010100.
    1. Elias S, Lam YL, Wittens CH. Mechanochemical ablation: status and results. Phlebology. 2013;28(Suppl 1):10–4. doi: 10.1177/0268355513477787.
    1. van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011;18:328–34. doi: 10.1583/11-3394.1.
    1. Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein® device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013;45:299–303. doi: 10.1016/j.ejvs.2012.12.004.
    1. Bishawi M, Bernstein R, Boter M, Draughn D, Gould CF, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2014;29:397–400. doi: 10.1177/0268355513495830.
    1. Kim PS, Bishawi M, Draughn D, Boter M, Gould C, Koziarski J, Bernstein R, Hamilton R. Mechanochemical ablation for symptomatic great saphenous vein reflux: a two-year follow-up. Phlebology. 2016 [Epub ahead of print].
    1. van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013;57:445–50. doi: 10.1016/j.jvs.2012.07.049.
    1. Vun SV, Rashid ST, Blest NC, Spark JI. Lower pain and faster treatment with mechanico-chemical endovenous ablation using ClariVein®. Phlebology. 2015;30:688–92. doi: 10.1177/0268355514553693.
    1. Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care. 1993;2:5–10. doi: 10.1136/qshc.2.1.5.
    1. Launois R, Mansilha A, Jantet G. International psychometric validation of the Chronic Venous Disease quality of life Questionnaire (CIVIQ-20) Euro J Vasc Endovasc Surg. 2010;40:783–9. doi: 10.1016/j.ejvs.2010.03.034.
    1. Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003;37:410–9. doi: 10.1067/mva.2003.152.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992;30:473–83. doi: 10.1097/00005650-199206000-00002.
    1. McHorney CA, Ware JE, Jr, Raczek AE. The MOS 36-item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247–63. doi: 10.1097/00005650-199303000-00006.
    1. McHorney CA, Ware JE, Jr, Lu JF, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32:40–66. doi: 10.1097/00005650-199401000-00004.
    1. The EuroQol Group EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Dolan P, Gudex C, Kind P, Williams A. The time trade-off method: results from a general population study. Health Econ. 1996;5:141–54. doi: 10.1002/(SICI)1099-1050(199603)5:2<141::AID-HEC189>;2-N.
    1. Garratt AM, Ruta DA, Abdalla MI, Russell IT. Responsiveness of the SF-36 and a condition-specific measure of health for patients with varicose veins. Qual Life Res. 1996;5:223–34. doi: 10.1007/BF00434744.
    1. Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg. 1999;30:710–9. doi: 10.1016/S0741-5214(99)70110-2.
    1. Michaels JA, Campbell WB, Brazier JE, MacIntyre JB, Palfreyman SJ, Ratcliffe J, Rigby K. Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial) Health Technol Assess. 2006;10(13):1–196. doi: 10.3310/hta10130.
    1. De Maeseneer M, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, Smith PC. Union Internationale de Phlebologie. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins – UIP consensus document. Eur J Vasc Endovasc Surg. 2011;42:89–102. doi: 10.1016/j.ejvs.2011.03.013.
    1. Bootun R, Lane T, Dharmarajah B, Lim CS, Najem M, Renton S, Sritharan K, Davies AH. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: the Multicentre Venefit™ versus ClariVein® for varicose veins trial. Phlebology. 2016;31:61–5. doi: 10.1177/0268355514551085.
    1. Almieda JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomised study (RECOVERY study) J Vasc Interv Radiol. 2009;20:752–9. doi: 10.1016/j.jvir.2009.03.008.
    1. Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD. Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm) Eur J Vasc Endovasc Surg. 2010;40:246–53. doi: 10.1016/j.ejvs.2010.02.026.
    1. Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg. 2011;254:876–81. doi: 10.1097/SLA.0b013e318230af5a.
    1. Coleridge-Smith P, Labropoulos N, Partsch H, Myers K, Nicolaides A, Cavezzi A. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs – UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg. 2006;31:83–92. doi: 10.1016/j.ejvs.2005.07.019.
    1. Cavezzi A, Labropoulos N, Partsch H, Ricci S, Caggiati A, Myers K, Nicolaides A, Smith PC, UIP Duplex ultrasound investigation of the veins in the chronic venous disease of the lower limbs – UIP consensus document. Part II. Anatomy. Eur J Vasc Endovasc Surg. 2006;31:288–99. doi: 10.1016/j.ejvs.2005.07.020.

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