Department of Neurosurgery and Key Laboratory of Neurotrauma, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.
Department of Epidemiology, College of Preventive Medicine, Army Medical University (Third Military Medical University), Chongqing, China.
Int J Stroke. 2024 Jun;19(5):587-592. doi: 10.1177/17474930241232292. Epub 2024 Feb 19.
Neuroendoscopy is a minimally invasive procedure for clot evacuation in intracerebral hemorrhage (ICH) which may have advantages compared with open surgical evacuation procedures. The application of neuroendoscopy in ICH has attracted increasing attention in recent years. However, it remains unclear whether it could improve outcomes in patients with ICH.
The aim of this study is to explore the efficacy and safety of neuroendoscopic hematoma evacuation surgery compared with standard conservative treatment for spontaneous deep supratentorial cerebral hemorrhage.
The Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage (NESICH) Trial is a multicenter, randomized, controlled, open-label, blinded-endpoint clinical trial. Up to 560 eligible subjects with acute deep supratentorial ICH will be randomly assigned (1:1) to receive either neuroendoscopic hematoma evacuation or standard conservative treatment at more than 30 qualified neurosurgery centers in China.
The primary endpoint is the proportion of patients with a good functional outcome (mRS score 0-3) in both groups at 180 days after onset. The main safety endpoints include all-cause mortality at 7, 30, and 180 days, rebleeding at 3, 7, and 30 days, and serious complications within 180 days.
NESICH will provide high-quality evidence for the efficacy and safety of neuroendoscopic hematoma evacuation surgery in ICH patients.
ClinicalTrials.gov NCT05539859.
神经内镜是一种治疗脑出血（ICH）的微创方法，与开颅手术清除血肿相比可能具有优势。近年来，神经内镜在 ICH 中的应用引起了越来越多的关注。然而，目前尚不清楚它是否能改善 ICH 患者的预后。
本研究旨在探讨神经内镜血肿清除术与标准保守治疗自发性幕上深部脑出血的疗效和安全性。
《神经内镜脑出血治疗疗效和安全性研究（NESICH）》是一项多中心、随机、对照、开放标签、盲终点临床试验。将 560 例符合条件的急性幕上深部 ICH 患者按 1:1 随机分配至神经内镜血肿清除组或标准保守治疗组，在全国 30 余家合格的神经外科中心进行。
主要结局为发病后 180 天两组患者良好功能结局（mRS 评分 0-3）的比例。主要安全性结局包括两组患者在发病后 7、30 和 180 天的全因死亡率、3、7 和 30 天的再出血率以及 180 天内的严重并发症发生率。
NESICH 将为神经内镜血肿清除术治疗 ICH 患者的疗效和安全性提供高质量证据。
ClinicalTrials.gov NCT05539859。
