Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Department of Education and Research, Catharina Hospital, The Netherlands.
Eur J Vasc Endovasc Surg. 2022 Jul;64(1):119-127. doi: 10.1016/j.ejvs.2022.05.003. Epub 2022 May 7.
Neurogenic thoracic outlet syndrome (NTOS) is one of the most controversial clinical entities in medicine. Several major case series have shown promising results of surgery; however, solid scientific evidence is lacking. The aim of this trial was to objectify the effect of thoracic outlet decompression (TOD).
A single centre (high volume, tertiary TOS centre), non-blinded, randomised controlled trial was conducted with parallel group design. Patients with a diagnosis of NTOS refractory to conservative therapy were randomised to one of two intervention arms, receiving either a transaxillary thoracic outlet decompression (TA-TOD) or continued conservative treatment. After three months, the conservative treated group was also offered a TA-TOD. The primary outcome was change in Disability of the Arm, Shoulder and Hand (DASH) questionnaire score. Secondary outcomes were changes in Cervical Brachial Symptoms Questionnaire (CBSQ), TOS disability scale, and quality of life scores. Outcomes were assessed at baseline, three, six, and 12 months after inclusion.
Fifty patients were enrolled in this trial: 25 in the TA-TOD group and 25 in the continued conservative treatment group. Follow up was completed in 24 and 22 patients, respectively. At three months, there was a statistically significant difference in DASH scores (TA-TOD: mean 45.15, 95% confidence interval [CI] 38.08 - 52.21; conservative treatment: mean 64.92, 95% CI 57.54 - 72.30; p < .001). All patients in the conservative treatment group applied for surgery three months after randomisation. After surgery of the conservative treatment group, there was no statistically significant difference between the groups for all primary and secondary outcome measures.
TA-TOD for NTOS is effective in patients who do not respond to conservative treatment. Trial register number: NL63986.100.17.
神经源性胸廓出口综合征（NTOS）是医学中最具争议的临床实体之一。几项主要的病例系列研究显示手术有较好的效果，但缺乏确凿的科学证据。本试验旨在客观评估胸廓出口减压术（TOD）的效果。
采用单中心（高容量、三级 TOS 中心）、非盲、随机对照试验，平行分组设计。对经保守治疗无效的 NTOS 患者进行随机分组，分别接受经腋路胸廓出口减压术（TA-TOD）或继续保守治疗。3 个月后，对接受保守治疗的患者也提供 TA-TOD 治疗。主要结局是手臂、肩部和手部残疾问卷（DASH）评分的变化。次要结局是颈椎臂症状问卷（CBSQ）、TOS 残疾量表和生活质量评分的变化。在纳入后 3、6 和 12 个月评估结局。
本试验纳入了 50 例患者：TA-TOD 组 25 例，继续保守治疗组 25 例。分别有 24 例和 22 例患者完成了随访。3 个月时，DASH 评分有统计学显著差异（TA-TOD：平均 45.15，95%置信区间[CI] 38.08-52.21；保守治疗：平均 64.92，95%CI 57.54-72.30；p<0.001）。继续保守治疗组的所有患者在随机分组后 3 个月均申请手术。在对保守治疗组进行手术后，两组所有主要和次要结局指标均无统计学显著差异。
对于经保守治疗无效的 NTOS 患者，TA-TOD 有效。试验注册号：NL63986.100.17。
