PREservation Versus Thermal Ablation (PRETA)

PREservation Versus Thermal Ablation of the Incompetent Great Saphenous Vein in Varicose Veins Treatment

This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).

Study Overview

• Status: Active, not recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: ASVAL; Procedure: EVLA

Detailed Description

Full venous duplex ultrasonography was performed using Medical ultrasound scan. Cognizant of the negative consequences of standing and sitting for long periods of time (e.g. venous hypertension, venous reflux), we scheduled investigations for early morning, thus ensuring examination of the physiological status of the venous system in each patient. Ultrasound examinations of reflux at the saphenofemoral junction (SFJ) were performed using the Valsalva maneuver. Ultrasound examination of GSV reflux was performed by manually compressing the calf followed by sudden release. Reverse flow that lasted more than 0.5 seconds was considered pathological. Preoperative venous duplex mapping was done in the upright position. Further measurements of the GSV diameter 15 cm below the SFJ level were conducted to describe the severity of varicose veins more accurately.

The diameter of GSV at the 15-cm below the SFJ level was the main criterion to identify two groups of patients. Those with the GSV diameter ≤ 6 mm were treated with ASVAL. If the diameter of GSV was > 6 mm, EVLA with concomitant phlebectomy was performed.

All surgical procedures were accomplished by the same surgeon, using tumescent local anesthesia (i.e. 0,1% lidocaine and sodium bicarbonate solution without epinephrine).The EVLA was done under duplex guidance with a 1560-nm diode laser using bare fibres via a Seldinger wire technique. The GSV was cannulated at the lowest point of the reflux. The laser fiber was advanced below the SFJ at the level of v. epigastrica sup. after which the GSV was ablated during gradual withdrawal of the fibre. The 15 Watts laser power was delivered in a continuous pull back traction. The average applied linear endovenous energy dose (LEED) was 75,3 J/cm.

Peripheral side branches were removed by multiple stab avulsions in both groups. After the treatment, the leg was wrapped in sterile absorbent bandages, and compression stockings class II (23-32 mm Hg) were put on and recommended to wear for two weeks. All patients were discharged on the day of the treatment and were invited to a follow-up duplex ultrasonography (DUS) on the 1st post-operative day, 2 years and 5 years after the operation (patients were contacted by phone). DUS at follow-up visits was carried out by an independent specialist who was not involved in the initial treatment of the patients. To report clinical recurrence after EVLA we have used Group d' Evaluation des Lasers et de l'Echographie Vasculare (GELEV) score.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Ihar Ihnatovich, MD, Prof; Phone Number: +375447811210; Email: iniini67@gmail.com

Study Locations

• Belarus
  • Dzerzhinski Ave., 83
    • Minsk, Dzerzhinski Ave., 83, Belarus, 220116
      • Educational Institution"Belarusian State Medical University"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria

Description

Inclusion Criteria:

• Great saphenous vein (GSV) incompetence with reflux at least down to the knee level
• Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C3
• Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations)

Exclusion Criteria:

• Previous surgical groin exploration, except herniotomy
• Small saphenous vein, anterior or posterior accessory saphenous vein incompetence at the same limb
• Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome
• Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASVAL - group; GSV diameter ≤ 6 mm	Procedure: ASVAL; Ambulatory Selective Varices Ablation under Local Anesthesia
EVLA-group; GSV diameter > 6 mm	Procedure: EVLA; Endovenous Laser Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)	2-5 years
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).	None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)	2-5 years
Number of Participants with venous oedema from absent (score 0) to severe (score 3).	None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)	2-5 years
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).	None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)	2-5 years
Number of Participants with inflammation from absent (score 0) to severe (score 3).	None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)	2-5 years
Number of Participants with induration from absent (score 0) to severe (score 3).	None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)	2-5 years
Number of Participants with active ulcers from absent (score 0) to severe (score 3).	None (0), 1 (1), 2 (2), more than 2 (3)	2-5 years
Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3).	None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)	2-5 years
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).	None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)	2-5 years
Number of Participants with compression therapy from absent (score 0) to severe (score 3).	Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)	2-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1)	Visible or palpable varicosity with a diameter of less than 3 mm after surgery (0). Visible or palpable varicosity with a diameter of more than 3 mm after surgery (1).	2-5 years

Collaborators and Investigators

• Sponsor: Belarusian State Medical University

Publications and helpful links

General Publications

• Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3.
• Pittaluga P, Chastanet S. Persistent incompetent truncal veins should not be treated immediately. Phlebology. 2015 Mar;30(1 Suppl):98-106. doi: 10.1177/0268355515569141.
• Chastanet S, Pittaluga P. Influence of the competence of the sapheno-femoral junction on the mode of treatment of varicose veins by surgery. Phlebology. 2014 May;29(1 suppl):61-65. doi: 10.1177/0268355514529207. Epub 2014 May 19.
• van Neer P, Kessels FG, Estourgie RJ, de Haan EF, Neumann MA, Veraart JC. Persistent reflux below the knee after stripping of the great saphenous vein. J Vasc Surg. 2009 Oct;50(4):831-4. doi: 10.1016/j.jvs.2009.05.021. Epub 2009 Jul 12.
• Zolotukhin IA, Seliverstov EI, Zakharova EA, Kirienko AI. Short-term results of isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) in primary varicose veins disease. Phlebology. 2017 Oct;32(9):601-607. doi: 10.1177/0268355516674415. Epub 2016 Oct 19.
• Harlander-Locke M, Jimenez JC, Lawrence PF, Derubertis BG, Rigberg DA, Gelabert HA. Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries. J Vasc Surg. 2013 Jul;58(1):166-72. doi: 10.1016/j.jvs.2012.12.054. Epub 2013 Apr 6.
• Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg. 2005 Sep;42(3):488-93. doi: 10.1016/j.jvs.2005.05.014.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): July 23, 2019
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Long-term efficacy; GSV; ASVAL; EVLA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 20140451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
• IPD Sharing Time Frame: 01.2020
• IPD Sharing Access Criteria: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No