A Randomised Clinical Trial Comparing Standard Cannula Delivered Foam Sclerotherapy, Catheter Directed Foam Sclerotherapy and ClariVein® Mechanochemical Ablation in the Management of Superficial Venous Insufficiency.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- technical success rate of treatment at 1 year
研究概览
简要总结
Leaking valves in the veins of the legs causes veins to become large and bloated. These swollen veins are called "varicose veins" and are a very common problem, affecting more than a third of all adults in the UK. Varicose veins reduce people's quality of life by causing problems such as pain, itching and restless legs. Varicose veins may also damage the skin over time causing problems such as bleeding, skin colour changes, eczema and even break-down in the skin which is called an ulcer. Newer, "key-hole" methods of treating leaky veins have been developed as an alternative to surgery and can be performed under local anaesthetic with the patient awake. Rather than cuts in the skin, these minimally invasive techniques are performed through tiny stab wounds; little larger than needle holes. The varicose vein is then destroyed from within, usually using heat to burn the inside of the vein. These procedures are popular; with a rapid recovery and a very high success rate. However these methods also require the vein to be surrounded by a large volume of dilute local anaesthetic which can to be slightly painful to administer. A technique called "Foam sclerotherapy" involves the injection of a drug which has been mixed into a foam. This goes into the vein and causes it to stick shut. This procedure is near painless to perform as very few, small local anaesthetic injections are required; however the chance for a successful treatment first time are lower and patients may need to return for repeat treatments to successfully treat the vein.
The aim of this study is to see whether the success rates for this technique can be improved. One method "catheter directed foam sclerotherapy" involves the delivery of the foam through a catheter (a long very thin tube), so that large lengths of vein can be treated through a single hole. The final method "ClariVein" again uses a catheter; but this time the catheter has a small wire on the end which spins around inside the vein; similar to an edge strimmer in the garden; except it irritates the vein: rather than cutting it. This irritation makes the vein more susceptible to the drug which can again be applied directly to the vein wall whilst it is still active. Early results show that this final method is very successful; however the equipment is more expensive than for the other two.
This study will randomly allocate willing participants with varicose veins to receive one of these three treatments to see whether the two newer treatments can improve the success rates and quality of life improvements seen with foam sclerotherapy, whilst also allowing near painless treatment, without significant complications, at an appropriate cost.
详细描述
. Investigational Plan Study Design This is a single centre three armed parallel group study with equal randomisation. The trial will be conducted in the Academic Vascular Surgical Unit of Hull York Medical School based at Hull Royal Infirmary, a university teaching hospital.
Target population The target population for this study are individuals with symptoms of SVI with ultrasound evidence of axial vein reflux and who have agreed to receive treatment for their axial vein reflux.
Recruitment Each patient referred to the vascular service with symptomatic SVI is assessed. Patients who potentially meet the inclusion criteria will be made aware of this research study and provided with the appropriate information, including the patient information sheet (see appendix 1). Patients will be given an opportunity to think about the invitation to participate and discuss with family/friends or other healthcare professionals if desired. Patients expressing an interest in participation will be offered an appointment for a screening visit with a study investigator.
Randomisation and Blinding Randomisation Participants will be randomised to one of the three treatments. Randomisation will be conducted by a sealed envelope system. Once enrolled in the study, efforts will be made to assess and manage all participants as outlined in the allocated treatment protocol until the pre-determined end-point of the study or until participant withdrawal. Following randomisation the participant's GP will be informed of the intended treatment modality Blinding Due to the nature of the procedures involved it will not be possible to blind the participant or clinical team as to which group the participant is allocated. Bias will be limited by the use of objective measurements, standardised protocols, use of patient reported outcomes and standardised assessor outcomes.
Power Calculation In order to detect a clinically significant difference in technical success of 15% with a power of 80% and a significance of 5%; 73 participants per group will be required. Assuming a 10% drop out rate we therefore aim to recruit 80 participants per group. The study will therefore randomise 240 participants in total over the 3 study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •• Aged 18 or over
- •Symptomatic superficial venous insufficiency; Clinical grades C2 - C6; which will likely benefit from treatment in the opinion of an experienced specialist and the participant
- •Superficial axial incompetence with proposed treatment lengths of >10cm. This axis may be a great saphenous vein (GSV), anterior accessory saphenous vein (ASV), small saphenous vein (SSV) or Giacomini vein (GV). Multiple veins can be treated.
- •The proposed treatment length is straight enough to be cannulated with the catheter devices and the SVI is suitable for treatment with any modality in the study in the view of an experienced specialist
- •Willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent
排除标准
- •• Inability to give informed written consent
- •Unsuitable for any of the treatments in the opinion of a suitably experienced specialist.
- •Unwilling or inability to comply with the requirements for follow-up visits.
- •Known allergy to any of the key medications used in the treatment protocols
- •Known right to left circulatory shunt
- •Evidence of deep venous thrombosis or occlusion
- •Active or recent thrombophlebitis (within 6 weeks)
- •Impalpable foot pulses and an Ankle-Brachial Pressure Index of less than 0.8
- •Pregnancy
- •Active malignancy
- •Immobility
研究组 & 干预措施
Foam Sclerotherapy Group
The axial vein will be cannulated under local anaesthesia and ultrasound guidance with the patient reclined in a supine position for GSV or ASV treatment, prone position if SSV or GV treatment.
The foam is then prepared by the Tessari technique by the surgeon. Two 2-ml syringes will be connected via a three way stop-cock tap and a 5 micron filter in series (Braun Medical, Sheffield, UK). The syringes will contain 1 part Sodium Tetradecyl Sulphate 3% and 3 parts air. In practice 0.5ml of 3% STS will be drawn up against 2 ml of air. The foam will be produced by at least 20 passages from syringe to syringe through the filter.
Up to 2ml of foam will be injected into each cannula under ultrasound control to observe venous spasm, followed by gentle massaging of the skin to propagate the foam through the segment of vein treated.
干预措施: Sodium Tetradecyl Sulphate (STS) (Drug)
Catheter Directed Foam Sclerotherapy (CDS) Group
The straight segment of axial vein will be cannulated under local anaesthesia at the lowest point of demonstrable reflux and a guide-wire inserted to facilitate the placement of the catheter system.The appropriate Unifuse® catheter will be selected and deployed through the introducer sheath and advanced to within 2cm of the junction or perforator at the upper limit of incompetence or the top of the incompetent segment in the case of segmental reflux. A 1:3 foam of 3% STD will be produced as described for FS. At this point the patient will be repositioned into a Trendelenburg position (head up)
干预措施: Sodium Tetradecyl Sulphate (STS) (Drug)
ClariVein Group (CV) Treatment
The straight segment of axial vein will be cannulated under local anaesthesia at the lowest point of demonstrable reflux and the ClariVein device 4-F micro sheath will be introduced up the vein via a guide wire as per manufacturer's instructions. Concentration of STD will depend on axial vein to be treated; if treating GSV or ASV 1.5% STD liquid will be used, if SSV or GV 1.0% STD liquid will be used. Volume of STD to be prepared for the CV treatment will be calculated using a dosage chart provided by the manufacturer
干预措施: Sodium Tetradecyl Sulphate (STS) (Drug)
结局指标
主要结局
technical success rate of treatment at 1 year
时间窗: 1 year
The primary outcome of this trial is the technical success rate of treatment at 1 year. The ultrasound appearances of the axial vein will be categorised as: * Fully occluded * Partial recanalisation (≤15% by length) * Widespread recanalisation (\>15% by length).
次要结局
- Disease Specific Quality of Life (Aberdeen Varicose Vein Questionnaire AVVQ)(1 Year)