Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein

Official title

Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial

Overview

This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein. Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments. Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening. In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate: How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.

Detailed description

Introduction:

Ultrasound-guided foam sclerotherapy is a widely used method for the treatment of lower limb varicose veins. Its main advantages include applicability in patients at high surgical risk and immediate or early return to daily activities. However, it requires a higher number of reinterventions compared to other techniques due to increased rates of venous recanalization, particularly in larger-caliber veins. In contrast, mechanochemical ablation shares these advantages and is associated with lower recanalization rates.

Objective:

To compare ultrasound-guided foam sclerotherapy of the great saphenous vein (GSV) with mechanochemical ablation using the Flebogrif® catheter in the treatment of chronic venous insufficiency (CVI) associated with GSV disease. The primary endpoints will be quality of life assessment and GSV occlusion rate, as determined by lower limb venous color Doppler ultrasonography over the proposed follow-up period. Secondary endpoints include the incidence of treatment-related complications and pain level during the procedure.

Patients and Methods:

A total of 50 patients with primary varicose veins will be selected. Inclusion criteria include lower limb pain, edema, or skin changes such as hyperpigmentation, eczema, and lipodermatosclerosis (CEAP classification C2-C4, EpAsPr), as well as GSV insufficiency with a diameter between 6 and 12 mm measured at the mid-thigh using color Doppler ultrasonography. Clinical evaluations and ultrasound examinations will be conducted at the venous disease outpatient clinic, and procedures will be performed in the minor surgery operating room of the University of São Paulo Hospital.

This will be a prospective randomized study, with patients allocated into two groups according to the treatment technique.

Group 1: Percutaneous puncture and ultrasound-guided injection of sclerosant foam through a short 18G catheter.

Group 2: Use of the Flebogrif® catheter, positioned under ultrasound guidance 2 cm from the saphenofemoral junction, followed by catheter withdrawal combined with sclerosant foam injection.

In both groups, 20 mL of 0.9% saline solution will be infused prior to polidocanol administration. The GSV puncture site will depend on the extent of insufficiency (segmental or total), being performed at the knee or medial malleolar region, respectively, after local anesthesia with 2% lidocaine without vasoconstrictor and without infiltration along the venous course.

For knee-level puncture, a tourniquet will be applied distal to the access site and maintained for 5 minutes after foam injection to prevent dispersion into healthy venous segments.

In all patients, varicose tributaries will be treated immediately after the GSV procedure using 1% polidocanol sclerotherapy.

Expected Results:

Mechanochemical ablation is expected to demonstrate a higher target vein occlusion rate with lower recanalization rates, without increased procedural pain and with at least a comparable complication rate to ultrasound-guided foam sclerotherapy. This study aims to contribute to the refinement of treatment strategies, seeking greater efficacy with monotherapy.

Interventions

• Device Flebogrif
  Mechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam.
• Drug Polidocanol foam sclerotherapy
  Polidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium.

Primary outcome measures

• Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire [Time frame: From enrollment to the end of treatment at 365 days after procedure]
• Disease Severity Score: Venous Clinical Severity Score (VCSS) [Time frame: From enrollment to the end of treatment at 365 days after procedure]
• Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006 [Time frame: From enrollment to the end of treatment at 365 days after procedure]

Secondary outcome measures (2)

• Treatment complications [Time frame: One to 365 after procedure]
• Pain Level During Procedure: Visual Analog Pain Scale [Time frame: Pain level during the procedure]

Eligibility criteria

Inclusion criteria

• CEAP Classification C2, 3 or 4
• Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.

Exclusion criteria

• Allergy to sclerosing substances
• Deep venous thrombosis, stroke, or pulmonary embolism
• Local or generalized infection at the sclerotherapy site
• Prolonged immobilization
• Asymptomatic patent foramen ovale
• Pregnancy Occlusive peripheral arterial disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Hospital da Clínicas da FMUSP — São Paulo

Publications

• Epstein D, Onida S, Bootun R, Ortega-Ortega M, Davies AH. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Health. 2018 Aug;21(8):911-920. doi: 10.1016/j.jval.2018.01.012. Epub 2018 Mar 15. PMID 30098668
• Petrone A, Peluso A, Ammollo RP, Turchino D, Del Guercio L, Andreucci M, Serra R, Bracale UM. Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience. Phlebology. 2022 Aug;37(7):522-528. doi: 10.1177/02683555221092194. Epub 2022 Apr 25. PMID 35466820
• Whing J, Nandhra S, Nesbitt C, Stansby G. Interventions for great saphenous vein incompetence. Cochrane Database Syst Rev. 2021 Aug 11;8(8):CD005624. doi: 10.1002/14651858.CD005624.pub4. PMID 34378180
• Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific PMID 18277340

Identifiers

NCT: NCT07561320 · 83198024.0.0000.0068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗