Comparative randomized clinical trial of Steam Ablation versus Endovenous Laser Ablation for the treatment of Great Saphenous Veins

The treatment of varicose veins reduces the symptoms and complications of
chronic venous insufficiency and improves HRQOL of patients. Surgery has been
the standard of care in the treatment of saphenous varicose veins. The great
saphenous vein (GSV) is traditionally treated by high ligation at the
saphenofemoral junction (SFJ) followed by a short stripping to the knee. Most
commonly, the small saphenous vein (SSV) is ligated at the saphenopopliteal
junction (SPJ) only. Recurrence rates after surgery are about 25% and 50% at 5
years for the GSV and SSV, respectively. A study with a mean follow-up of 34
years showed recurrence in 60% of 125 limbs after SFJ ligation and GSV
stripping. Failure after surgery may be due to neovascularization, double
saphenous vein system, technical and tactical failure (up to 30%), and/or
incomplete procedure. Other disadvantages of surgical therapy are the use of
general or epidural anesthesia, presence of at least two fairly long scars,
postoperative down-time, and risk of adverse events such as femoral artery
and/or vein damage, wound infection, neurologic injury (about 7% in short to
40% in long stripping of GSV) and lymphatic complications. To improve
efficacy, patients* HRQOL, and treatment satisfaction and to reduce serious
side effects, costs, and postoperative pain, new minimally invasive techniques,
such as ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation
(EVLA), and radiofrequency ablation (RFA), have been introduced in the last
decade. The mechanism of ablation of the latter two therapies is based on
heating (of at least 85 degrees Celsius) of the venous structure including the
creation of intravascular *steam bubbles* either using laser emission or
radiofrequency. From this mechanistic perspective, a new minimally invasive
endovenous therapy has been developed that generates and administers high
pressure steam in the varicose vein (i.e., Steam Vein Sclerosis [SVS ]). The
advantages of this new procedure are mechanistic, costs and possibly patient
satifaction. The steam generator is less expensive than existing laser and
radiofrequency devices and requires little to no maintenance. In contrast to
EVLA, RFA and UGFS, Steam Ablation uses sterile water which is natural body*s
substance and has not the possible disadvantage of inducing harm using or
generating exogenous substances. Because the induced temperature rise is
limited (in accordance with RFA), it is likely that the treatment related
symptoms (i.e., pain and bruising) and complication rate is lower than EVLA,
which may increase patient*s comfort and treatment safety.

To test whether the anatomical success rate of Steam Ablation is not inferior
to that of EVLA in treatment of GSV insufficiency and compare the treatment
related complications, patient reported outcomes and cost-effectiveness
analyses between EVLA and Steam Ablation.

A non-inferiority randomized clinical trial with one year follow up.

Endovenous Laser Ablation or Steam Ablation. Both procedures are endovenous
techniques based on heating the varicose vein from inside reulting in closure
of the treated vein.

The treatments within the trial setting are either identical or almost the same
as the treatment that would be offered to the regular patient. The aim of the
trial is to compare effectivity, complication rate, safety,
patient-satisfaction and cost-effectiveness. The patient participating in the
Trial should attend the Department of Dermatology once more than the regular
patient, which will take approximately 15 minutes. Furthermore patients are
asked to fill in two questionnaires, which will take approximately 30 minutes.