Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Varicose Vein

NCT05707169 | Unknown DMC

• 1 other identifier: R.22.09.1805 - 2022/09/06
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT). In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV.

Conditions

Varicose Veins; Venous Reflux; Venous Insufficiency; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Recurrence

  both duplex ultrasound and the clinical examination. A varicose vein that had not been observed before or previously been marked by the patient on the AVVQ form was considered to be a recurrent varicose vein (owing to neo-vascularization or dilation of pre-existing veins).

  6 months

Secondary Outcomes (1)

• Heat induced thrombosis

  6 months

Study Arms (2)

Two Centimeters from Saphenofemoral Junction

EXPERIMENTAL

Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture. Using 1470 nm laser and a radial fibre for less discomfort. The catheter is placed 2-2.5 cm distal to the sapheno-femoral junction. Tumescence with a mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

Procedure: Saphenous Ablation; Device: Endogenous Laser Ablation (EVLA); Drug: mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

Zero point Ablation

EXPERIMENTAL

The catheter is positioned exactly at the terminal valve of the SFJ (kissing the valve).

Procedure: Saphenous Ablation; Device: Endogenous Laser Ablation (EVLA)

Interventions

Saphenous Ablation PROCEDURE

Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture.

Two Centimeters from Saphenofemoral Junction; Zero point Ablation

Endogenous Laser Ablation (EVLA) DEVICE

Endogenous Laser Ablation (EVLA)

Two Centimeters from Saphenofemoral Junction; Zero point Ablation

mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline DRUG

mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

Two Centimeters from Saphenofemoral Junction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary symptomatic VVS (CEAP, C3-C6), sapheno-femoral junction (SFJ) incompetence, and GSV reflux from the groin to below the knee

You may not qualify if:

• history of venous surgery, suspected or proven deep venous thrombosis, history of DVT, reflux of deep veins to distal limb, duplication of GSV, and patients' refusal to participate in the trial.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, 35511, Egypt

Location

Related Links

• Rasmussen LH, Bjoern L, Lawaerz M, Lawaetz B, Blemings A, Eklof B. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years. Eur J Vasc Endovasc Surg 2010;39
• Subwongcharoen S, Praditphol N, Chitwiset S. Endovenous microwave ablation of varicose veins: in vitro, live swine model, and clinical study. Surg Laparosc Endosc Percutan Tech 2009;19(2):170e4.

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency; Varicose Ulcer

Interventions

Lidocaine; Levobupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Laser Ablation of varicose veins

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: January 31, 2023
• Study Start: January 4, 2023
• Primary Completion: February 4, 2024
• Study Completion: May 4, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)