Great Saphenous Vein Electrocoagulation

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02139085
• Other study ID #: IDPC 2014
• Status: Recruiting
• Phase: Phase 2
• First received: May 12, 2014
• Last updated: August 6, 2014
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2014
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: Fabio H Rossi, PHD
• Phone: 551142276668
• Email: vascular369[@]me.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: July 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins
• Venous Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardilogia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GSV occlusion	GSV occlusion verified by blinded DS operator	3 months	No
Primary	GSV occlusion	GSV occlusion verified by blinded DS operator	6 months	No
Secondary	Pain VAS	Pain VAS by blinded Outcomes Assessor	1 week	Yes
Secondary	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	Yes
Secondary	Post operative sensory abnormality	Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia.; Assessment by blinded Outcomes Assessor	1 week	Yes
Secondary	Venous Clinical Severity Score (VCSS)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months	No
Secondary	Aberdeen Varicose Vein Questionnaire (AVVQ)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months	No
Secondary	Deep Venous Thrombosis (DVT)	Presence of DVT verified by blinded DS operator	1 week	Yes
Secondary	Clinical Etiology Anatomy Pathophysiology (CEAP)	Difference from baseline. Assessment by blinded Outcomes Assessor.	6 months	No

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