Clinical trial NCT01637181: Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins
Official title: Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Insufficiency of Great Saphenous Vein
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.

Detailed description: \* Study type: Interventional. Randomized comparative clinical trial..

* Outcome measures:

  * Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
  * Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (\> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
* Outcome measures time frame:

Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.

\* Focus of the study: Varicose great saphenous veins (GSV)

* Intervention information:

  * Intervention name: endovenous laser ablation (EVLA)
  * Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
  * Arm information: both interventions are active comparators.
* Locations:

Rotterdam, Zuid-Holland, The Netherlands

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec, and diameter of vein \> 0.5 cm
* Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
* 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
* Diameter of GSV ≤ 0.5 mm at puncture site

Primary outcomes:
measure: Pain score and use of painkillers
timeFrame: 1 week post treatment
measure: Treatment satisfaction
timeFrame: 1 week post treatment
measure: Health related quality of life
timeFrame: 0 and 12 weeks post treatment
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: The adverse events will be assessed at 1 and 12 weeks post treatment.
measure: Occlusion of the treated GSV (effectiveness)
timeFrame: The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References:
citation: Malskat WS, Giang J, De Maeseneer MG, Nijsten TE, van den Bos RR. Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence. Br J Surg. 2016 Feb;103(3):192-8. doi: 10.1002/bjs.10035. Epub 2015 Dec 14.