ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial

Overview

Journal Stroke

Specialties Cardiology & Vascular Diseases
Neurology

Date 2016 Oct 26

PMID 27758940

Citations 71

Authors

Paul Vespa

Daniel Hanley

Joshua Betz

Alan Hoffer

Johnathan Engh

Robert Carter

Peter Nakaji

Chris Ogilvy

Jack Jallo

Warren Selman

Amanda Bistran-Hall

Karen Lane

Nichol McBee

Jeffery Saver

Richard E Thompson

Neil Martin

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Surgical interventions for spontaneous supratentorial intracerebral haemorrhage: a systematic review and network meta-analysis.

Huan J, Yao M, Ma Y, Mei F, Liu Y, Ma L EClinicalMedicine. 2024; 79:102999.

PMID: 39720609 PMC: 11667076. DOI: 10.1016/j.eclinm.2024.102999.

Early minimally invasive image-guided eNdoscopic evacuation of iNTracerebral hemorrhage: a phase II pilot trial.

Hallenberger T, Fischer U, Ghosh N, Kuhle J, Guzman R, Bonati L Front Neurol. 2024; 15:1484255.

PMID: 39628893 PMC: 11611861. DOI: 10.3389/fneur.2024.1484255.

Robot-assistant visualized minimally invasive aspiration (RAVMIA) technique for intracerebral hemorrhage evacuation: Case series.

Luo Z, Li C, Du X, Wang T Heliyon. 2024; 10(21):e39803.

PMID: 39524743 PMC: 11544056. DOI: 10.1016/j.heliyon.2024.e39803.

Comparison of strategies based on DTI visualisation for stereotactic minimally invasive surgery in the treatment of moderate-volume thalamo-basal ganglia cerebral haemorrhage: a protocol for a multicenter prospective study.

Yang S, Liu Y, Wang S, Peng H, Qi X, Cai Z BMC Surg. 2024; 24(1):351.

PMID: 39521976 PMC: 11549819. DOI: 10.1186/s12893-024-02644-4.

Bioactive Self-Assembled Nanoregulator Enhances Hematoma Resolution and Inhibits Neuroinflammation in the Treatment of Intracerebral Hemorrhage.

Yu W, Che C, Yang Y, Zhao Y, Liu J, Chen A Adv Sci (Weinh). 2024; 12(1):e2408647.

PMID: 39520083 PMC: 11714160. DOI: 10.1002/advs.202408647.

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