Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a randomised, controlled, open-label, blinded endpoint trial(NESICH)
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Published:2024-01-30
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Volume:
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ISSN:1747-4930
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Container-title:International Journal of Stroke
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language:en
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Short-container-title:International Journal of Stroke
Author:
Wang Long1,
Zhou Tengyuan1,
Wang Pangbo1,
Zhang Shuixian1,
Yi Yin1,
Chen Lin1,
Duan Haijun1,
Wu Na2,
Feng Hua1,
Hu Rong1ORCID
Affiliation:
1. Department of Neurosurgery and Key Laboratory of Neurotrauma, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China
2. Department of Epidemiology, College of Preventive Medicine, Army Medical University (Third
Military Medical University), Chongqing, China
Abstract
Background: Neuroendoscopy is a minimally invasive procedure for clot evacuation in intracerebral haemorrhage (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.
Funder
Joint project of Chongqing Health Commission and Science and Technology Bureau, and the First Affiliated Hospital of Army Medical University Clinical Research Project
Publisher
SAGE Publications
Subject
Neurology,Neurology (clinical)