Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: A randomized, controlled, open-label, blinded endpoint trial (NESICH).

IF 6.3 2区医学 Q1 CLINICAL NEUROLOGY

International Journal of Stroke Pub Date : 2024-06-01 Epub Date: 2024-02-19 DOI:10.1177/17474930241232292

Long Wang, Tengyuan Zhou, Pangbo Wang, Shuixian Zhang, Yi Yin, Lin Chen, Haijun Duan, Na Wu, Hua Feng, Rong Hu

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引用次数: 0

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Outcomes: 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.

Discussion: NESICH will provide high-quality evidence for the efficacy and safety of neuroendoscopic hematoma evacuation surgery in ICH patients.

Trial registration: ClinicalTrials.gov NCT05539859.

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神经内镜手术治疗脑出血的有效性和安全性：随机对照、开放标签、盲法终点试验（NESICH）。

背景：神经内镜是一种微创手术，用于脑内出血（ICH）血块的清除，与开放性手术清除血块相比具有优势。近年来，神经内镜在 ICH 中的应用日益受到关注。然而，它是否能改善 ICH 患者的预后仍不清楚：本研究旨在探讨神经内镜血肿清除手术与自发性深脑室上出血标准保守治疗相比的有效性和安全性：脑出血神经内镜手术的有效性和安全性（NESICH）试验是一项多中心、随机、对照、开放标签、盲终点临床试验。中国 30 多家有资质的神经外科中心将随机分配（1:1）多达 560 名符合条件的急性脑室上深部 ICH 受试者接受神经内镜血肿清除术或标准保守治疗：主要终点是两组患者在发病后180天功能预后良好（mRS评分0-3分）的比例。主要安全性终点包括7天、30天和180天的全因死亡率，3天、7天和30天的再出血率，以及180天内的严重并发症：NESICH将为ICH患者接受神经内镜血肿清除手术的有效性和安全性提供高质量的证据：试验注册：ClinicalTrials.gov NCT05539859。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Stroke 医学-外周血管病

CiteScore

13.90

自引率

6.00%

发文量

132

审稿时长

6-12 weeks

期刊介绍： The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.

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