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Abstract：
BACKGROUND: Intracerebral hemorrhage (ICH) is a common stroke type with high morbidity and mortality. There are mainly three surgical methods for treating ICH. Unfortunately, thus far, no specific surgical method has been proven to be the most effective. We carried out this study to investigate whether minimally invasive surgeries with endoscopic surgery or stereotactic aspiration (frameless navigated aspiration) will improve functional outcomes in patients with supratentorial ICH compared with small-bone flap craniotomy.
METHODS: In this parallel-group multicenter randomized controlled trial conducted at 16 centers, patients with supratentorial hypertensive ICH were randomized to receive endoscopic surgery, stereotactic aspiration, or craniotomy at a 1:1:1 ratio from July 2016 to June 2022. The follow-up duration was 6 months. Patients were randomized to receive endoscopic evacuation, stereotactic aspiration, or small-bone flap craniotomy. The primary outcome was favorable functional outcome, defined as the proportion of patients who achieved a modified Rankin scale (mRS) score of 0-2 at the 6-month follow-up.
RESULTS: A total of 733 patients were randomly allocated to three groups: 243 to the endoscopy group, 247 to the aspiration group, and 243 to the craniotomy group. Finally, 721 patients (239 in the endoscopy group, 246 in the aspiration group, and 236 in the craniotomy group) received treatment and were included in the intention-to-treat analysis. Primary efficacy analysis revealed that 73 of 219 (33.3%) in the endoscopy group, 72 of 220 (32.7%) in the aspiration group, and 47 of 212 (22.2%) in the craniotomy group achieved favorable functional outcome at the 6-month follow-up (P = .017). We got similar results in subgroup analysis of deep hemorrhages, while in lobar hemorrhages the prognostic outcome was similar among three groups. Old age, deep hematoma location, large hematoma volume, low preoperative GCS score, craniotomy, and intracranial infection were associated with greater odds of unfavorable outcomes. The mean hospitalization expenses were ¥92,420 in the endoscopy group, ¥77,351 in the aspiration group, and ¥100,947 in the craniotomy group (P = .000).
CONCLUSIONS: Compared with small bone flap craniotomy, endoscopic surgery and stereotactic aspiration improved the long-term outcome of hypertensive ICH, especially deep hemorrhages.
BACKGROUND: ClinicalTrials.gov Identifier: NCT02811614.
METHODS: In this parallel-group multicenter randomized controlled trial conducted at 16 centers, patients with supratentorial hypertensive ICH were randomized to receive endoscopic surgery, stereotactic aspiration, or craniotomy at a 1:1:1 ratio from July 2016 to June 2022. The follow-up duration was 6 months. Patients were randomized to receive endoscopic evacuation, stereotactic aspiration, or small-bone flap craniotomy. The primary outcome was favorable functional outcome, defined as the proportion of patients who achieved a modified Rankin scale (mRS) score of 0-2 at the 6-month follow-up.
RESULTS: A total of 733 patients were randomly allocated to three groups: 243 to the endoscopy group, 247 to the aspiration group, and 243 to the craniotomy group. Finally, 721 patients (239 in the endoscopy group, 246 in the aspiration group, and 236 in the craniotomy group) received treatment and were included in the intention-to-treat analysis. Primary efficacy analysis revealed that 73 of 219 (33.3%) in the endoscopy group, 72 of 220 (32.7%) in the aspiration group, and 47 of 212 (22.2%) in the craniotomy group achieved favorable functional outcome at the 6-month follow-up (P = .017). We got similar results in subgroup analysis of deep hemorrhages, while in lobar hemorrhages the prognostic outcome was similar among three groups. Old age, deep hematoma location, large hematoma volume, low preoperative GCS score, craniotomy, and intracranial infection were associated with greater odds of unfavorable outcomes. The mean hospitalization expenses were ¥92,420 in the endoscopy group, ¥77,351 in the aspiration group, and ¥100,947 in the craniotomy group (P = .000).
CONCLUSIONS: Compared with small bone flap craniotomy, endoscopic surgery and stereotactic aspiration improved the long-term outcome of hypertensive ICH, especially deep hemorrhages.
BACKGROUND: ClinicalTrials.gov Identifier: NCT02811614.
摘要：
背景：脑出血（ICH）是一种常见的卒中类型，具有高发病率和高死亡率。治疗ICH的手术方法主要有三种。不幸的是,到目前为止，没有特定的手术方法被证明是最有效的。我们进行了这项研究，以调查与小骨瓣开颅术相比，内镜手术或立体定向抽吸（无框导航抽吸）的微创手术是否会改善幕上ICH患者的功能预后。
方法：在16个中心进行的平行组多中心随机对照试验中，幕上高血压ICH患者随机接受内镜手术,立体定向抽吸,或开颅手术，从2016年7月到2022年6月，比例为1:1:1。随访6个月。患者随机接受内镜下疏散，立体定向抽吸,或者小骨瓣开颅术.主要结果是有利的功能结果，定义为6个月随访时改良Rankin量表(mRS)评分为0~2分的患者比例.
结果：总共733例患者被随机分为三组：243例内窥镜检查组，第247号发给愿望小组，243分给开颅手术组。最后,721例患者（内镜组239例，246在抽吸组中，开颅手术组236人)接受治疗并纳入意向治疗分析.初步疗效分析显示，内镜组219人中有73人(33.3%)，吸入组中220人中的72人（32.7%），在6个月的随访中，开颅手术组212人中有47人（22.2%）获得了良好的功能结局（P=0.017）。我们在深度出血的亚组分析中得到了类似的结果，而在大叶出血中，三组的预后结果相似。老年,深部血肿位置,血肿体积大，术前GCS评分低，开颅手术,颅内感染与更大的不良结局相关.内窥镜检查组的平均住院费用为92,420日元，¥77,351在抽吸组中，开颅手术组为100,947日元（P=.000）。
结论：与小骨瓣开颅手术相比，内镜手术和立体定向抽吸术改善了高血压ICH的长期预后,尤其是深度出血.
背景：ClinicalTrials.gov标识符：NCT02811614。
方法：在16个中心进行的平行组多中心随机对照试验中，幕上高血压ICH患者随机接受内镜手术,立体定向抽吸,或开颅手术，从2016年7月到2022年6月，比例为1:1:1。随访6个月。患者随机接受内镜下疏散，立体定向抽吸,或者小骨瓣开颅术.主要结果是有利的功能结果，定义为6个月随访时改良Rankin量表(mRS)评分为0~2分的患者比例.
结果：总共733例患者被随机分为三组：243例内窥镜检查组，第247号发给愿望小组，243分给开颅手术组。最后,721例患者（内镜组239例，246在抽吸组中，开颅手术组236人)接受治疗并纳入意向治疗分析.初步疗效分析显示，内镜组219人中有73人(33.3%)，吸入组中220人中的72人（32.7%），在6个月的随访中，开颅手术组212人中有47人（22.2%）获得了良好的功能结局（P=0.017）。我们在深度出血的亚组分析中得到了类似的结果，而在大叶出血中，三组的预后结果相似。老年,深部血肿位置,血肿体积大，术前GCS评分低，开颅手术,颅内感染与更大的不良结局相关.内窥镜检查组的平均住院费用为92,420日元，¥77,351在抽吸组中，开颅手术组为100,947日元（P=.000）。
结论：与小骨瓣开颅手术相比，内镜手术和立体定向抽吸术改善了高血压ICH的长期预后,尤其是深度出血.
背景：ClinicalTrials.gov标识符：NCT02811614。
