腔内激光消融术与使用ClariVein(®)进行机械化学消融术治疗浅静脉功能不全的比较（LAMA试验）：一项随机对照试验的研究方案
Endovenous laser ablation versus mechanochemical ablation with ClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial.
作者信息
Leung Clement C M, Carradice Daniel, Wallace Tom, Chetter Ian C
机构信息
Academic Vascular Unit, Hull York Medical School, University of Hull, Hull, HU3 2JZ, UK.
出版信息
Trials. 2016 Aug 24;17(1):421. doi: 10.1186/s13063-016-1548-1.
BACKGROUND
Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.
METHODS/DESIGN: The Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.
DISCUSSION
The aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02627846 , registered 8 December 2015 EudraCT number: 2015-000730-30 REC ref: 15/YH/0207 R&D ref: R1788.
背景
静脉内热消融技术，如静脉腔内激光消融术（EVLA），是治疗主干静脉曲张的推荐方法。然而，热消融技术的一个缺点是需要使用肿胀麻醉，这可能会让人感到不适。非热、非肿胀技术，如机械化学消融术（MOCA）具有潜在优势。MOCA通过旋转导丝对内皮造成物理损伤，并注入液体硬化剂。MOCA的初步经验显示效果良好且术后疼痛较轻。
方法/设计：激光消融与机械化学消融（LAMA）试验是一项单中心随机对照试验，140例患者将被随机分配接受EVLA或MOCA治疗。所有符合入选标准的原发性主干浅静脉功能不全（SVI）患者将被邀请参加本试验。主要结局指标为术中疼痛和1年时的技术疗效，技术疗效定义为目标静脉段完全闭塞，并使用双功超声进行评估。次要结局指标包括术后疼痛、镇痛药物使用、手术时间、临床严重程度、一般和疾病特异性生活质量、瘀斑、并发症、满意度、美观度、恢复日常活动和/或工作所需时间，以及EVLA或MOCA后的成本效益分析。两组均将基于意向性分析进行评估。
讨论
LAMA试验的目的是确定MOCA是否优于当前的一线治疗方法EVLA。两个主要假设是，MOCA可能引起的初始疼痛和功能障碍较少，从而使治疗更容易接受且恢复更快。第二个假设是，这可能会以疗效降低为代价，这可能导致复发增加并影响长期生活质量，增加二次手术的需求。
试验注册
ClinicalTrials.gov标识符：NCT02627846，于2015年12月8日注册；EudraCT编号：2015-000730-30；REC编号：15/YH/0207；研发编号：R1788。
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