Clinical trial NCT02046967: Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Official title: Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Varicose Veins of Leg With Long Saphenous Vein Distribution
Keywords: endovenous laser ablation
endovenous steam ablation
great saphenous veins
quality of life
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

Detailed description: The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 s, and diameter of vein \> 0.5 cm
* Symptoms of chronic venous insufficiency
* No prior treatment of the insufficient GSV
* Informed consent

Exclusion Criteria:

* Acute deep or superficial vein thrombosis
* Agenesis of deep vein system
* Vascular malformation or syndrome
* Post-thrombotic syndrome, occlusive type
* Pregnancy
* Immobility
* Allergy to lidocaine
* Arterial insufficiency

Primary outcomes:
measure: Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.
timeFrame: 52 weeks
Secondary outcomes:
measure: Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
timeFrame: 12 weeks
measure: Minor complications: ecchymosis, pain and hyperpigmentation.
timeFrame: 12 weeks
measure: Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
timeFrame: 12 weeks
measure: Treatment satisfaction
timeFrame: 2 weeks
measure: Pain score
timeFrame: 2 weeks
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Renate R van den Bos, MD, PhD
role: STUDY_DIRECTOR
References:
citation: van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30.