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: coma; endoscopic surgery; hemorrhagic; intracerebral hemorrhage; stroke.

Conflict of interest statement

Disclosures

Dr Martin receives paid consultant to Storz; Patent pending Endoscopic Surgery. The other authors report no conflicts.

© 2016 American Heart Association, Inc.

Figures

Figure 1.

Distribution of hematoma reduction by patient group. The stability volume (A), end of treatment volume (B), volume removed (C), and percent volume removed (D) for the medical and surgical groups are shown. ICH indicates intracerebral hemorrhage; and ITT, intention-to-treat.

Figure 2.

Distribution of modified Rankin Scale (mRS) over the 365-day follow-up period. mRS scores determined at 90, 180, 270, and 365 days after symptom onset are shown by treatment group. The mRS score of 0 is not displayed because none of the subjects achieved this score during the follow-up period.

Figure 3.

Kaplan–Meier. Summary of mortality in the surgical and medical groups.