PREservation Versus Thermal Ablation

Varicose Veins Clinical Trial

— PRETA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034329
• Other study ID #: 20140451
• Status: Active, not recruiting
• Start date: January 1, 2013
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2023
• Source: Belarusian State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 1, 2025
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• ASVAL
Ambulatory Selective Varices Ablation under Local Anesthesia
• EVLA
Endovenous Laser Ablation

Locations

Country	Name	City	State
Belarus	Educational Institution"Belarusian State Medical University"	Minsk	Dzerzhinski Ave., 83

Sponsors (1)

Lead Sponsor	Collaborator
Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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