用于脑出血的术中立体定向计算机断层扫描引导下的内镜手术（ICES）：一项多中心随机对照试验。
ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial.
作者信息
Vespa Paul, Hanley Daniel, Betz Joshua, Hoffer Alan, Engh Johnathan, Carter Robert, Nakaji Peter, Ogilvy Chris, Jallo Jack, Selman Warren, Bistran-Hall Amanda, Lane Karen, McBee Nichol, Saver Jeffery, Thompson Richard E, Martin Neil
机构信息
From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.).
出版信息
Stroke. 2016 Nov;47(11):2749-2755. doi: 10.1161/STROKEAHA.116.013837. Epub 2016 Oct 6.
BACKGROUND AND PURPOSE
Intracerebral hemorrhage (ICH) is a devastating disease without a proven therapy to improve long-term outcome. Considerable controversy about the role of surgery remains. Minimally invasive endoscopic surgery for ICH offers the potential of improved neurological outcome.
METHODS
We tested the hypothesis that intraoperative computerized tomographic image-guided endoscopic surgery is safe and effectively removes the majority of the hematoma rapidly. A prospective randomized controlled study was performed on 20 subjects (14 surgical and 4 medical) with primary ICH of >20 mL volume within 48 hours of ICH onset. We prospectively used a contemporaneous medical control cohort (n=36) from the MISTIE trial (Minimally Invasive Surgery and r-tPA for ICH Evacuation). We evaluated surgical safety and neurological outcomes at 6 months and 1 year.
RESULTS
The intraoperative computerized tomographic image-guided endoscopic surgery procedure resulted in immediate reduction of hemorrhagic volume by 68±21.6% (interquartile range 59-84.5) within 29 hours of hemorrhage onset. Surgery was successfully completed in all cases, with a mean operative time of 1.9 hours (interquartile range 1.5-2.2 hours). One surgically related bleed occurred peri-operatively, but no patient met surgical safety stopping threshold end points for intraoperative hemorrhage, infection, or death. The surgical intervention group had a greater percentage of patients with good neurological outcome (modified Rankin scale score 0-3) at 180 and 365 days as compared with medical control subjects (42.9% versus 23.7%; P=0.19).
CONCLUSIONS
Early computerized tomographic image-guided endoscopic surgery is a safe and effective method to remove acute intracerebral hematomas, with a potential to enhance neurological recovery.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770.
背景与目的
脑出血（ICH）是一种破坏性疾病，尚无经证实可改善长期预后的治疗方法。关于手术作用的争议仍然很大。脑出血的微创内镜手术有望改善神经功能预后。
方法
我们检验了以下假设：术中计算机断层扫描图像引导的内镜手术安全且能迅速有效清除大部分血肿。对20例脑出血发病48小时内原发性脑出血体积>20 mL的受试者（14例手术治疗和4例保守治疗）进行了一项前瞻性随机对照研究。我们前瞻性地使用了来自MISTIE试验（微创外科手术和r - tPA用于脑出血清除）的同期保守治疗队列（n = 36）。我们在6个月和1年时评估了手术安全性和神经功能预后。
结果
术中计算机断层扫描图像引导的内镜手术在出血发作后29小时内使出血体积立即减少68±21.6%（四分位间距59 - 84.5）。所有病例手术均成功完成，平均手术时间为1.9小时（四分位间距1.5 - 2.2小时）。围手术期发生1例手术相关出血，但没有患者达到术中出血、感染或死亡的手术安全停止阈值终点。与保守治疗组相比，手术干预组在180天和365天时神经功能预后良好（改良Rankin量表评分0 - 3）的患者百分比更高（42.9%对23.7%；P = 0.19）。
结论
早期计算机断层扫描图像引导的内镜手术是清除急性脑出血的一种安全有效的方法，具有促进神经功能恢复的潜力。
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