Catheter-directed Foam Sclerotherapy With Tumescence
Primary Purpose
Varicose Vein of Lower Limbs
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short catheter
Long catheter preceded by tumescence
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Vein of Lower Limbs
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Short catheter
Long catheter preceded by tumescence
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Great Saphenous Vein Occlusion Rate
It will be measured by ultrasound
Secondary Outcome Measures
Quality of Life Change
It will be measured by the application of the Aberdeen varicose vein questionnaire
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.
Full Information
NCT ID
NCT02753270
First Posted
April 21, 2016
Last Updated
November 13, 2017
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02753270
Brief Title
Catheter-directed Foam Sclerotherapy With Tumescence
Official Title
Catheter-directed Foam Sclerotherapy With Tumescence of the Great Saphenous Vein Versus Ultrasound Guided Foam Sclerotherapy: Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Vein of Lower Limbs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Long catheter preceded by tumescence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Short catheter
Intervention Description
Ultrasound Guided Foam Sclerotherapy in Great Saphenous Vein, measuring from 6 to 10 mm, with Short Catheter.
Intervention Type
Procedure
Intervention Name(s)
Long catheter preceded by tumescence
Intervention Description
Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, measuring from 6 to 10 mm, Preceded by Tumescence.
Primary Outcome Measure Information:
Title
Great Saphenous Vein Occlusion Rate
Description
It will be measured by ultrasound
Time Frame
Six months after the intervention
Secondary Outcome Measure Information:
Title
Quality of Life Change
Description
It will be measured by the application of the Aberdeen varicose vein questionnaire
Time Frame
Six months follow-up after the intervention
Title
Complications
Description
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.
Time Frame
From the intervention until six months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erasmo S Silva, PhD
Organizational Affiliation
São Paulo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18426039
Citation
Breu FX, Guggenbichler S, Wollmann JC. 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37 Suppl 71:1-29.
Results Reference
result
PubMed Identifier
19952380
Citation
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.
Results Reference
result
PubMed Identifier
20922783
Citation
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.
Results Reference
result
PubMed Identifier
17919946
Citation
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.
Results Reference
result
PubMed Identifier
21725957
Citation
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.
Results Reference
result
PubMed Identifier
16226898
Citation
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.
Results Reference
result
PubMed Identifier
11231246
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/18426039
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/19952380
Available IPD/Information Type
Literature Review
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/20922783
Available IPD/Information Type
Literature Review
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=In+vitro+effects+of+detergent+sclerosants+on+coagulation%2C+platelets+and+microparticles.
Available IPD/Information Type
Literature Review
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/21725957
Available IPD/Information Type
Literature Review
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/16226898
Available IPD/Information Type
Literature Review
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/11231246
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Catheter-directed Foam Sclerotherapy With Tumescence
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