轴向消融与反流源终端阻断（AAVTIRS）：一项随机对照试验。
Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial.
机构信息
University Hospital Galway, Galway, Ireland.
National University of Ireland Galway, Galway, Ireland.
出版信息
Trials. 2022 Jun 10;23(1):483. doi: 10.1186/s13063-022-06440-4.
BACKGROUND
Treatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA).
AIM
To determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy.
METHODS
AAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility.
RANDOMISATION
Random computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes.
BLINDING
Assessors reviewing wounds at follow -p visits will be blinded to patient allocation.
PRIMARY ENDPOINT
The proportion of ulcers healed within 6 months of enrolment.
DISCUSSION
This will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04484168. Registered on 23 July 2020.
背景
已证实治疗浅静脉反流可缩短溃疡愈合时间并降低溃疡复发风险。静脉反流源末端消融（TIRS）是一种替代传统静脉内消融或手术的方法，可通过向溃疡周围静脉丛内注射硬化泡沫来实现。TIRS 已被证明是有效的，而且根据我们的经验，当向患者提供 TIRS 作为轴向消融（AA）的替代方案时，许多患者更倾向于选择这种方法。
目的
比较采用静脉内 AA 治疗与溃疡周围泡沫硬化治疗 TIRS 的患者，其静脉性溃疡在治疗后 6 个月内的愈合比例是否存在差异。
方法
AAVTIRS 是一项评估者设盲的随机对照试验。将从罗斯康芒大学医院的专门溃疡诊所和戈尔韦大学医院的血管外科诊所招募患者。所有到溃疡诊所就诊的患者都将进行资格筛选。
随机分组
采用按溃疡大小分层的计算机生成随机序列。使用密封不透明信封隐藏分组信息。
盲法
在随访就诊时评估伤口的评估者将对患者分组情况设盲。
主要终点
纳入后 6 个月内溃疡愈合的比例。
讨论
这将是首次在静脉性溃疡管理中，采用经充分验证的随机试验对 TIRS 进行评估。简化静脉性溃疡的管理具有广泛的健康经济效益。如果发现 TIRS 优于或非劣于 AA，那么可以作为 AA 的替代方案，提供一种更经济、侵入性更小的注射治疗方法，以尝试促进静脉性溃疡的愈合。如果发现 AA 优于 TIRS，则表明在管理静脉性溃疡时接受消融治疗的所有患者都应充分治疗其浅静脉反流，这是基于 EVRA 试验的证据。
试验注册
ClinicalTrials.gov NCT04484168。于 2020 年 7 月 23 日注册。
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