Catheter-directed Foam Sclerotherapy With Tumescence of the Great Saphenous Vein Versus Ultrasound Guided Foam Sclerotherapy: Randomised Controlled Trial

University of Sao Paulo0 sites50 target enrollmentDecember 2014

ConditionsVaricose Vein of Lower Limbs

Overview

Phase: N/A
Intervention: Not specified
Conditions: Varicose Vein of Lower Limbs
Sponsor: University of Sao Paulo
Enrollment: 50
Primary Endpoint: Great Saphenous Vein Occlusion Rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

April 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Responsible Party

Principal Investigator

Jorgete Barreto dos Santos

Principal investigator

University of Sao Paulo

Eligibility Criteria

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.