Catheter-directed Foam Sclerotherapy With Tumescence

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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Vein of Lower Limbs
• Intervention / Treatment: Procedure: Short catheter; Procedure: Long catheter preceded by tumescence

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short catheter; Twenty-five patients will receive the sclerosant foam by a short catheter 18 G. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method.	Procedure: Short catheter; Ultrasound Guided Foam Sclerotherapy in Great Saphenous Vein, measuring from 6 to 10 mm, with Short Catheter.
Experimental: Long catheter preceded by tumescence; Twenty-five patients will be receive foam sclerosant by an angiographic catheter 4 French. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method.	Procedure: Long catheter preceded by tumescence; Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, measuring from 6 to 10 mm, Preceded by Tumescence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Great Saphenous Vein Occlusion Rate	It will be measured by ultrasound	Six months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Change	It will be measured by the application of the Aberdeen varicose vein questionnaire	Six months follow-up after the intervention
Complications	It will be considered: anaphylaxis;; superficial thrombophlebitis;; deep venous thrombosis;; pulmonary embolism;; visual disturbances;; migraine;; transient ischemic attack;; tissue necrosis;; intra arterial injection;; neurological injury;; edema;; skin pigmentation;; skin irritation;; burning after the sclerosant injection;; retaining clots.	From the intervention until six months follow-up

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Erasmo S Silva, PhD, Sao Paulo University

Publications and helpful links

General Publications

• Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60.
• Cavezzi A, Tessari L. Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection. Phlebology. 2009 Dec;24(6):247-51. doi: 10.1258/phleb.2009.009061.
• Breu FX, Guggenbichler S, Wollmann JC. 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37 Suppl 71:1-29.
• Gohel MS, Epstein DM, Davies AH. Cost-effectiveness of traditional and endovenous treatments for varicose veins. Br J Surg. 2010 Dec;97(12):1815-23. doi: 10.1002/bjs.7256. Epub 2010 Oct 4.
• Parsi K, Exner T, Connor DE, Ma DD, Joseph JE. In vitro effects of detergent sclerosants on coagulation, platelets and microparticles. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):731-40. doi: 10.1016/j.ejvs.2007.07.011. Epub 2007 Oct 4.
• Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.
• Coleridge-Smith P, Labropoulos N, Partsch H, Myers K, Nicolaides A, Cavezzi A. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):83-92. doi: 10.1016/j.ejvs.2005.07.019. Epub 2005 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 12683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Study Data/Documents

1. Study Protocol
2. Study Protocol
3. Literature Review
4. Literature Review
5. Literature Review
6. Literature Review
7. Literature Review