Great Saphenous Vein Electrocoagulation

A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.

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.

Study Overview

• Status: Unknown
• Conditions: Varicose Veins; Venous Disease
• Intervention / Treatment: Device: GSV Electrocoagulation; Device: GSV Radiofrequency

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04012-909
      • Recruiting
      • Instituto Dante Pazzanese de Cardilogia
      • Contact: Fabio H Rossi, PHD; Phone Number: 4120 551150856000; Email: vascular369@me.com
      • Principal Investigator: Fabio H Rossi, HD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GSV occlusion	GSV occlusion verified by blinded DS operator	3 months
GSV occlusion	GSV occlusion verified by blinded DS operator	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS	Pain VAS by blinded Outcomes Assessor	1 week
Post operative bruising	The bruised area traced manually, and the surface area estimated by placing the tracing on a square chart. Assessment by blinded Outcomes Assessor.	1 week
Post operative sensory abnormality	Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia. Assessment by blinded Outcomes Assessor	1 week
Venous Clinical Severity Score (VCSS)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months
Aberdeen Varicose Vein Questionnaire (AVVQ)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months
Deep Venous Thrombosis (DVT)	Presence of DVT verified by blinded DS operator	1 week
Clinical Etiology Anatomy Pathophysiology (CEAP)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months

Collaborators and Investigators

• Sponsor: Instituto Dante Pazzanese de Cardiologia
• Investigators: Principal Investigator: Fabio H Rossi, PHD, Dante Pazzanese

Publications and helpful links

General 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.
• Rossi FH, Izukawa NM, Silva DG, Chen J, Prakasan AK, Zamorano MM, Silva LM. Effects of electrocautery to provoke endovascular thermal injury. Acta Cir Bras. 2011 Oct;26(5):329-32. doi: 10.1590/s0102-86502011000500001.

Helpful Links

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Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: varicose veins; catheter ablation; Catheter Ablation, Electrical; Catheter Ablation, Radiofrequency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: IDPC 2014