Catheter-directed Foam Sclerotherapy With Tumescence
Catheter-directed Foam Sclerotherapy With Tumescence
Foam sclerotherapy has been established as another option of treatment for varicose veins of
 the lower limbs. Its advantages are the application to patients with high surgical risk and
 immediate return to usual activities. Comparing to laser and radiofrequency, it has lower
 cost and is less painful. Nevertheless, it requires more re-interventions due to venous
 recanalization.
The aim of this study is to compare two ultrasound guided foam sclerotherapy (UGFS)
 techniques to great saphenous vein (GSV) by injecting the sclerosant foam through a short
 catheter without perivenous tumescence and through a long catheter with saline anesthetic
 tumescence. Method: selection of 50 patients with primary varicose veins, edema (C3EpAsPr of
 the CEAP classification) and with GSV measuring 6 - 10 mm, 3 cm below the saphenofemoral
 junction, identified by ultrasound. The study is taking place at the vascular surgery
 ambulatory of the University of São Paulo. It is a prospective controlled trial with random
 allocation in two groups according to the foam sclerosant technique injection. The group 1
 will receive the sclerosant foam by a short catheter 18 G and in the group 2 an angiographic
 catheter 4 Fr. will be used. All patients will be treated with 3% polidocanol foam prepared
 with a three-way tap and two plastic disposable syringes, according to Tessari's method. The
 access will be by puncture and its place will depend on the insufficient venous extension. It
 will be at the level of the knee to treat proximal GSV or at the medial ankle to treat the
 full length of the vein. In group 2, after inserting the long catheter into the GSV, a saline
 anesthetic solution will be infiltrated around the insufficient venous segment under
 ultrasound guidance to reduce its diameter. The long catheter will be continuously flushed
 with 0.9% saline solution until the foam sclerosant injection. In the cases of treating only
 the proximal GSV, patients will receive a continuous compression with tourniquet below the
 knee just before the injection and maintained for 5 minutes thereafter. Then, the tributaries
 in all 50 patients will be treated by phlebectomy under tumescent local anesthesia.
 Color-duplex ultrasound follow-up is programmed to 7, 28 and 168 days after the treatment.
 The first one is to check the possibility of deep venous thrombosis, the second is to verify
 the occlusion rate and the need of another foam injection. The last ultrasound is to check
 the final occlusion rate.

 Hypothesis: UGFS with long catheter preceded of tumescence has a large occlusion rate of the
 GSV with monotherapy.
Inclusion Criteria:

 -  Age equal to or greater than 18 years;

 -  patients with varicose veins with edema - CEAP classification C3EpAsPr;

 -  Great saphenous vein incompetence, segmental and total, with diameter from 6 to 10 mm
 in proximal thigh, 3 cm from the saphenous femoral junction measured by ultrasound.

 Exclusion Criteria:

 -  Allergy to the sclerosant substance;

 -  acute deep vein thrombosis or pulmonary thromboembolism;

 -  local infection in the area of sclerotherapy or severe systemic infection;

 -  prolonged immobilisation;

 -  symptomatic patent foramen ovale;

 -  pregnancy;

 -  peripheral arterial occlusive disease;

 -  short saphenous vein incompetence association;

 -  refusal to sign the consent form;

 -  nonadherence to outpatient treatment.