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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Vein of Lower Limbs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 21, 2016
    Last Updated
    November 13, 2017
    Sponsor
    University of Sao Paulo
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    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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