Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Closure rate of the target vein/ Absence of refluxing vein
研究概览
简要总结
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
详细描述
Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 80 years of age at the time of enrollment
- •Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
- •Diameter of saphenous vein between 2mm to 20mm (with standing position)
- •One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
- •Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5
排除标准
- •Previous treatment in targeted vein segment
- •Tortuous vein in which the delivery catheter cannot be inserted
- •Aneurysm of target vein segment >20 mm
- •Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
- •Known hypercoagulable disorder
- •Active malignancy
- •Regular use of systemic anticoagulation
- •Current use of systemic anticoagulant
- •Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
- •Unable to comply with the schedule and protocol evaluations
- •Unable to ambulate
- •Currently pregnant or breast feeding
- •Known sensitivity to cyanoacrylate adhesives
- •Symptomatic peripheral arterial disease with ankle-brachial index <0.9
- •Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
- •Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol
研究组 & 干预措施
Cyanoacrylate closure
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
干预措施: Cyanoacrylate closure (Procedure)
Cyanoacrylate closure
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
干预措施: Surgical stripping (Procedure)
Surgical stripping
For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.
干预措施: Cyanoacrylate closure (Procedure)
Surgical stripping
For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.
干预措施: Surgical stripping (Procedure)
结局指标
主要结局
Closure rate of the target vein/ Absence of refluxing vein
时间窗: 3 months
The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator.
次要结局
- Satisfaction of the patients: satisfaction rate(1, 3, 6, 12 and 24 months after treatment)
- Ecchymosis(3 days)
- Acceptability of Quality of life score(1, 3, 6, 12 and 24 months after treatment)
- Perioperative pain with visual analog scale(3 days)
- Venous Clinical Severity Score(1, 3, 6, 12 and 24 months after treatment)
研究者
Jin Hyun Joh
Associate professor
Kyung Hee University Hospital at Gangdong