ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial
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. METHO...
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| Published in | Stroke (1970) Vol. 47; no. 11; pp. 2749 - 2755 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Heart Association, Inc
01.11.2016
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| Subjects | |
| Online Access | Get full text |
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| 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—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00224770. |
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| AbstractList | 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—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00224770. 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. 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. 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). 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. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770. 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.BACKGROUND AND PURPOSEIntracerebral 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.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.METHODSWe 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.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).RESULTSThe 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).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.CONCLUSIONSEarly computerized tomographic image-guided endoscopic surgery is a safe and effective method to remove acute intracerebral hematomas, with a potential to enhance neurological recovery.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770.CLINICAL TRIAL REGISTRATIONURL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770. |
| Author | Selman, Warren Hanley, Daniel Nakaji, Peter McBee, Nichol Bistran-Hall, Amanda Carter, Robert Saver, Jeffery Lane, Karen Jallo, Jack Thompson, Richard E. Vespa, Paul Martin, Neil Hoffer, Alan Betz, Joshua Ogilvy, Chris Engh, Johnathan |
| AuthorAffiliation | From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.) |
| AuthorAffiliation_xml | – name: From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.) |
| Author_xml | – sequence: 1 givenname: Paul surname: Vespa fullname: Vespa, Paul organization: From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.) – sequence: 2 givenname: Daniel surname: Hanley fullname: Hanley, Daniel – sequence: 3 givenname: Joshua surname: Betz fullname: Betz, Joshua – sequence: 4 givenname: Alan surname: Hoffer fullname: Hoffer, Alan – sequence: 5 givenname: Johnathan surname: Engh fullname: Engh, Johnathan – sequence: 6 givenname: Robert surname: Carter fullname: Carter, Robert – sequence: 7 givenname: Peter surname: Nakaji fullname: Nakaji, Peter – sequence: 8 givenname: Chris surname: Ogilvy fullname: Ogilvy, Chris – sequence: 9 givenname: Jack surname: Jallo fullname: Jallo, Jack – sequence: 10 givenname: Warren surname: Selman fullname: Selman, Warren – sequence: 11 givenname: Amanda surname: Bistran-Hall fullname: Bistran-Hall, Amanda – sequence: 12 givenname: Karen surname: Lane fullname: Lane, Karen – sequence: 13 givenname: Nichol surname: McBee fullname: McBee, Nichol – sequence: 14 givenname: Jeffery surname: Saver fullname: Saver, Jeffery – sequence: 15 givenname: Richard surname: Thompson middlename: E. fullname: Thompson, Richard E. – sequence: 16 givenname: Neil surname: Martin fullname: Martin, Neil |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27758940$$D View this record in MEDLINE/PubMed |
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| Keywords | intracerebral hemorrhage endoscopic surgery stroke coma hemorrhagic |
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| PublicationTitle | Stroke (1970) |
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| PublicationYear | 2016 |
| Publisher | American Heart Association, Inc |
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| References | e_1_3_4_3_2 e_1_3_4_2_2 e_1_3_4_9_2 e_1_3_4_8_2 e_1_3_4_7_2 e_1_3_4_5_2 e_1_3_4_4_2 e_1_3_4_11_2 e_1_3_4_12_2 e_1_3_4_20_2 e_1_3_4_10_2 e_1_3_4_21_2 e_1_3_4_15_2 e_1_3_4_16_2 e_1_3_4_13_2 e_1_3_4_14_2 e_1_3_4_19_2 e_1_3_4_17_2 e_1_3_4_18_2 Gong C (e_1_3_4_6_2) 2001; 48 29061841 - Stroke. 2017 Nov;48(11):e335. doi: 10.1161/STR.0000000000000153 |
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| Snippet | BACKGROUND AND PURPOSE—Intracerebral hemorrhage (ICH) is a devastating disease without a proven therapy to improve long-term outcome. Considerable controversy... Intracerebral hemorrhage (ICH) is a devastating disease without a proven therapy to improve long-term outcome. Considerable controversy about the role of... |
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| SubjectTerms | Cerebral Hemorrhage - diagnostic imaging Cerebral Hemorrhage - mortality Cerebral Hemorrhage - surgery Female Follow-Up Studies Humans Male Minimally Invasive Surgical Procedures Neuroendoscopy - adverse effects Neuroendoscopy - methods Outcome and Process Assessment, Health Care Pilot Projects Surgery, Computer-Assisted - adverse effects Surgery, Computer-Assisted - methods Tomography, X-Ray Computed - methods |
| Title | ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial |
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