Clinical trial NCT03722134: Mechanochemical Ablation vs Thermal Ablation
Official title: Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: Great saphenous vein
Thermal ablation
Mechanochemical ablation
Randomized controlled trial
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study aim was to assess the applicability and safety of MOCA in short term as well as occlusion rate and disease specific quality of life one year after the procedure, and compare it with currently used thermal ablation methods of laser ablation (EVLA) and radiofrequency ablation (RFA) in a randomized controlled trial.

Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
Primary purpose: TREATMENT

Brief summary: Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.

Detailed description: During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.

Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.

The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.

During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.

At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.

Eligibility criteria: Inclusion Criteria:

* clinical classification of venous disease C2-C4
* ultrasound-verified reflux in the GSV
* mean GSV diameter in the thigh between 5 and 12 millimetres
* informed consent.

Exclusion Criteria:

* body mass index (BMI) of over 40
* peripheral arterial disease
* lymphoedema
* pregnancy
* allergy to either the sclerosant or lidocaine
* severe general illness
* malignancy
* previous deep venous thrombosis
* previous varicose vein intervention in the same leg
* coagulation disorders

Primary outcomes:
measure: Occlusion rate
timeFrame: One year after the treatment
measure: Freedom from reflux
timeFrame: One year after the treatment
measure: Disease-specific quality of life
timeFrame: One year after the treatment
measure: Occlusion rate
timeFrame: three years after the treatment
measure: Freedom from reflux
timeFrame: three years after the treatment
measure: Disease-specific quality of life
timeFrame: three years after the treatment
measure: Occlusion rate
timeFrame: five years after the treatment
measure: Freedom from reflux
timeFrame: five years after the treatment
measure: Disease-specific quality of life
timeFrame: five years after the treatment
Secondary outcomes:
measure: Peroperative and immediate postoperative pain
timeFrame: During the procedure, immediately after, and at one week after the treatment
measure: Sick leave
timeFrame: During the immediate postoperative period up to one month
measure: Pain medication
timeFrame: During the immediate postoperative period up to one month
measure: 30-day occlusion rate
timeFrame: 30 days after the treatment
measure: Complications
timeFrame: Up to five years after the treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Vahaaho S, Halmesmaki K, Mahmoud O, Alback A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):652-659. doi: 10.1016/j.jvsv.2020.08.007. Epub 2020 Aug 12.
citation: Vahaaho S, Mahmoud O, Halmesmaki K, Alback A, Noronen K, Vikatmaa P, Aho P, Venermo M. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019 Apr;106(5):548-554. doi: 10.1002/bjs.11158.