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

ICES Investigators

doi:10.1161/STROKEAHA.116.013837

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

ICES Investigators

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	2749-2755
Number of pages	7
Journal	Stroke
Volume	47
Issue number	11
DOIs	https://doi.org/10.1161/STROKEAHA.116.013837
State	Published - Nov 2016
Externally published	Yes

Keywords

Cerebral Hemorrhage/diagnostic imaging
Female
Follow-Up Studies
Humans
Male
Minimally Invasive Surgical Procedures
Neuroendoscopy/adverse effects
Outcome and Process Assessment, Health Care
Pilot Projects
Surgery, Computer-Assisted/adverse effects
Tomography, X-Ray Computed/methods

Access to Document

10.1161/STROKEAHA.116.013837

Cite this

@article{d3c58aa0e244479dbd74c0a9bc90a3c6,

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

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.",

keywords = "Cerebral Hemorrhage/diagnostic imaging, Female, Follow-Up Studies, Humans, Male, Minimally Invasive Surgical Procedures, Neuroendoscopy/adverse effects, Outcome and Process Assessment, Health Care, Pilot Projects, Surgery, Computer-Assisted/adverse effects, Tomography, X-Ray Computed/methods",

author = "\{ICES Investigators\} and Paul Vespa and Daniel Hanley and Joshua Betz and Alan Hoffer and Johnathan Engh and Robert Carter and Peter Nakaji and Chris Ogilvy and Jack Jallo and Warren Selman and Amanda Bistran-Hall and Karen Lane and Nichol McBee and Jeffery Saver and Thompson, \{Richard E\} and Neil Martin",

note = "{\textcopyright} 2016 American Heart Association, Inc.",

year = "2016",

month = nov,

doi = "10.1161/STROKEAHA.116.013837",

language = "English",

volume = "47",

pages = "2749--2755",

journal = "Stroke",

issn = "0039-2499",

number = "11",

}

TY - JOUR

T1 - ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage

T2 - A Multicenter Randomized Controlled Trial

AU - ICES Investigators

AU - Vespa, Paul

AU - Hanley, Daniel

AU - Betz, Joshua

AU - Hoffer, Alan

AU - Engh, Johnathan

AU - Carter, Robert

AU - Nakaji, Peter

AU - Ogilvy, Chris

AU - Jallo, Jack

AU - Selman, Warren

AU - Bistran-Hall, Amanda

AU - Lane, Karen

AU - McBee, Nichol

AU - Saver, Jeffery

AU - Thompson, Richard E

AU - Martin, Neil

PY - 2016/11

Y1 - 2016/11

N2 - 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.

AB - 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.

KW - Cerebral Hemorrhage/diagnostic imaging

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Minimally Invasive Surgical Procedures

KW - Neuroendoscopy/adverse effects

KW - Outcome and Process Assessment, Health Care

KW - Pilot Projects

KW - Surgery, Computer-Assisted/adverse effects

KW - Tomography, X-Ray Computed/methods

U2 - 10.1161/STROKEAHA.116.013837

DO - 10.1161/STROKEAHA.116.013837

M3 - Article

C2 - 27758940

SN - 0039-2499

VL - 47

SP - 2749

EP - 2755

JO - Stroke

JF - Stroke

IS - 11

ER -