Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CEAP Classification C2, 3 or 4
- •Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
排除标准
- •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
研究组 & 干预措施
Great saphenous vein insufficiency (2)
25 limbs with great saphenous vein insufficiency
干预措施: Polidocanol foam sclerotherapy (Drug)
Great saphenous vein insufficiency (1)
25 limbs with great saphenous vein insufficiency
干预措施: Flebogrif (Device)
Great saphenous vein insufficiency (1)
25 limbs with great saphenous vein insufficiency
干预措施: Polidocanol foam sclerotherapy (Drug)
Great saphenous vein insufficiency (2)
25 limbs with great saphenous vein insufficiency
干预措施: Flebogrif (Device)
结局指标
主要结局
Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire
时间窗: From enrollment to the end of treatment at 365 days after procedure
Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire will be used. Score from 0 to 100, where 0 is the best and 100 is the worst quality of life related to varicose veins.
Disease Severity Score: Venous Clinical Severity Score (VCSS)
时间窗: From enrollment to the end of treatment at 365 days after procedure
Venous Clinical Severity Score (VCSS) will be used. Score from 0 to 30, where 0 means asymptomatic patient and 30 means more symptomatic patient as possible.
Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006
时间窗: From enrollment to the end of treatment at 365 days after procedure
Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006, will be used. Classification where 0 means reflux greater than 1 second, 1 means reflux less than 1 second, and 2 means no reflux.
次要结局
- Treatment complications(One to 365 after procedure)
- Pain Level During Procedure: Visual Analog Pain Scale(Pain level during the procedure)
研究者
Antonio Eduardo Zerati
Principal Investigator
University of Sao Paulo