早期微创内镜引导手术治疗脑出血的安全性和技术效果：荷兰脑出血手术试验预试验研究。
Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study.
机构信息
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Geert Grooteplein Zuid 10, PO-box 9101, 6500HB, Nijmegen, The Netherlands.
Department of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
出版信息
Acta Neurochir (Wien). 2023 Jun;165(6):1585-1596. doi: 10.1007/s00701-023-05599-2. Epub 2023 Apr 27.
BACKGROUND
Previous randomised controlled trials could not demonstrate that surgical evacuation of intracerebral haemorrhage (ICH) improves functional outcome. Increasing evidence suggests that minimally invasive surgery may be beneficial, in particular when performed early after symptom onset. The aim of this study was to investigate safety and technical efficacy of early minimally invasive endoscopy-guided surgery in patients with spontaneous supratentorial ICH.
METHODS
The Dutch Intracerebral Haemorrhage Surgery Trial pilot study was a prospective intervention study with blinded outcome assessment in three neurosurgical centres in the Netherlands. We included adult patients with spontaneous supratentorial ICH ≥10mL and National Institute of Health Stroke Scale (NIHSS) score ≥2 for minimally invasive endoscopy-guided surgery within 8 h after symptom onset in addition to medical management. Primary safety outcome was death or increase in NIHSS ≥4 points at 24 h. Secondary safety outcomes were procedure-related serious adverse events (SAEs) within 7 days and death within 30 days. Primary technical efficacy outcome was ICH volume reduction (%) at 24 h.
RESULTS
We included 40 patients (median age 61 years; IQR 51-67; 28 men). Median baseline NIHSS was 19.5 (IQR 13.3-22.0) and median ICH volume 47.7mL (IQR 29.4-72.0). Six patients had a primary safety outcome, of whom two already deteriorated before surgery and one died within 24 h. Sixteen other SAEs were reported within 7 days in 11 patients (of whom two patients that already had a primary safety outcome), none device related. In total, four (10%) patients died within 30 days. Median ICH volume reduction at 24 h was 78% (IQR 50-89) and median postoperative ICH volume 10.5mL (IQR 5.1-23.8).
CONCLUSIONS
Minimally invasive endoscopy-guided surgery within 8 h after symptom onset for supratentorial ICH appears to be safe and can effectively reduce ICH volume. Randomised controlled trials are needed to determine whether this intervention also improves functional outcome.
TRIAL REGISTRATION
Clinicaltrials.gov : NCT03608423, August 1st, 2018.
背景
先前的随机对照试验未能证明颅内血肿清除术（ICH）能改善功能预后。越来越多的证据表明，微创外科可能有益，尤其是在症状发作后早期进行。本研究旨在探讨早期微创内镜引导手术治疗自发性幕上ICH 的安全性和技术疗效。
方法
荷兰颅内出血手术试验（Dutch Intracerebral Haemorrhage Surgery Trial）是一项前瞻性干预研究，在荷兰的三个神经外科中心进行，采用盲法结局评估。我们纳入了发病 8 小时内接受微创内镜引导手术治疗且 NIHSS 评分≥2 分的成人自发性幕上 ICH 患者，除了药物治疗外，还进行微创内镜引导手术治疗。主要安全性结局为 24 小时时死亡或 NIHSS 评分增加≥4 分。次要安全性结局为 7 天内与手术相关的严重不良事件（SAE）和 30 天内死亡。主要技术疗效结局为 24 小时时 ICH 体积减少（%）。
结果
我们纳入了 40 名患者（中位年龄 61 岁；IQR 51-67；28 名男性）。基线 NIHSS 中位数为 19.5（IQR 13.3-22.0），ICH 体积中位数为 47.7mL（IQR 29.4-72.0）。6 名患者出现主要安全性结局，其中 2 名患者在手术前已经恶化，1 名患者在 24 小时内死亡。11 名患者中有 16 名患者在 7 天内报告了 16 例其他 SAE（其中 2 名患者已经出现主要安全性结局），均与器械无关。共有 4 名（10%）患者在 30 天内死亡。24 小时时 ICH 体积减少中位数为 78%（IQR 50-89），术后 ICH 体积中位数为 10.5mL（IQR 5.1-23.8）。
结论
发病 8 小时内接受微创内镜引导手术治疗幕上 ICH 似乎是安全的，并且可以有效地减少 ICH 体积。需要开展随机对照试验来确定这种干预措施是否也能改善功能预后。
试验注册
Clinicaltrials.gov：NCT03608423，2018 年 8 月 1 日。
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