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Great Saphenous Vein Electrocoagulation

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ClinicalTrials.gov Identifier: NCT02139085
Recruitment Status : Unknown
Verified August 2014 by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia.
Recruitment status was:  Recruiting
First Posted : May 15, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia

Study Description
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Brief Summary:

Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical results has never been studied before.

Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial.

Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when level of p <0.05.


Condition or disease Intervention/treatment Phase
Venous Disease Varicose Veins Device: GSV Electrocoagulation Device: GSV Radiofrequency Phase 2

Detailed Description:

All patients included in the study will be preoperatively examined to evaluate the severity of venous disease, using the CEAP classification, VCSS and AVVQ. They will undergo venous DS with the aim of investigating GSV insufficiency, its caliber and depth and presence of previous thrombophlebitis.

Patients will be randomized on the day of surgery with an electronic table of random numbers:

Group 1:Electrocoagulation treatment. Group 2: Radiofrequency treatment.

Patients and outcomes assessor will be blinded to the group of endovenous treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
Study Start Date : August 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GSV Electrocoagulation
GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds
 Device: GSV Electrocoagulation
The energy source will be the Electrosurgical Generator (FX-Valley Lab; USA) and the GSV thermo ablation will be performed with 60 Watts per 10 seconds. The catheter and electrocoagulation device head will be pulled back in increments of 2 cm also to overlap the treatment sites.
Active Comparator: GSV Radiofrequency
GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm
 Device: GSV Radiofrequency
The second generation RF device (Closure FAST; Covidien, USA) will be used. The treatment component of the device is 7 cm in length and works with a segmental pullback protocol. Once the catheter is in position, activation of the generator delivers 20- seconds cycles of energy to the catheter tip, which heats the vein wall to 120 o C.


Outcome Measures
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Primary Outcome Measures :
  1. GSV occlusion [ Time Frame: 3 months ]
    GSV occlusion verified by blinded DS operator

  2. GSV occlusion [ Time Frame: 6 months ]
    GSV occlusion verified by blinded DS operator


Secondary Outcome Measures :
  1. Pain VAS [ Time Frame: 1 week ]
    Pain VAS by blinded Outcomes Assessor

  2. Post operative bruising [ Time Frame: 1 week ]

    The bruised area traced manually, and the surface area estimated by placing the tracing on a square chart.

    Assessment by blinded Outcomes Assessor.


  3. Post operative sensory abnormality [ Time Frame: 1 week ]

    Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia.

    Assessment by blinded Outcomes Assessor


  4. Venous Clinical Severity Score (VCSS) [ Time Frame: 6 months ]
    Difference from baseline. Assessment by blinded Outcomes Assessor.

  5. Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 6 months ]
    Difference from baseline. Assessment by blinded Outcomes Assessor.

  6. Deep Venous Thrombosis (DVT) [ Time Frame: 1 week ]
    Presence of DVT verified by blinded DS operator

  7. Clinical Etiology Anatomy Pathophysiology (CEAP) [ Time Frame: 6 months ]
    Difference from baseline. Assessment by blinded Outcomes Assessor.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV

Exclusion Criteria:

  • Previous varicose vein surgery with removal of the GSV
  • Pregnant women
  • Patients in use of anticoagulants
  • Known thrombophilia
  • Presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin
  • GSV diameter < 5mm and > 12 mm
  • Previous deep vein thrombosis
  • Peripheral arterial disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139085


Contacts
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Contact: Fabio H Rossi, PHD 551142276668 vascular369@me.com
Contact: Nilo M Izukawa, PHD 551150856000 ext 4122 nilosmk.ops@terra.com.br

Locations
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Brazil
Instituto Dante Pazzanese de Cardilogia Recruiting
São Paulo, SP, Brazil, 04012-909
Contact: Fabio H Rossi, PHD    551150856000 ext 4120    vascular369@me.com   
Principal Investigator: Fabio H Rossi, HD         
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Investigators
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Principal Investigator: Fabio H Rossi, PHD Dante Pazzanese
More Information
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Additional Information:

Publications:
Rossi FH, Beteli CB, Zamorano MB, Silva LM. Immediate effects of endovascular electrocauterization in lower limb varicose veins. J Vasc Bras 11(3): 305-309, 2012.

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Responsible Party: Fabio H Rossi, vascular surgeon PhD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02139085    
Other Study ID Numbers: IDPC 2014
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia:
varicose veins
catheter ablation
Catheter Ablation, Electrical
Catheter Ablation, Radiofrequency
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases