Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage (EndoSurofICH)

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Surgery; Intracerebral Hemorrhage

Treatments: Procedure: Intra-endoscopic surgery; Procedure: Placebo:stereotactic aspiration surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02515903

NFYY-NSD-001

Details and patient eligibility

About

Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.

Full description

Although the incidence and mortality of spontaneous intracerebral hemorrhage (ICH) have been decreased with the improved management of high blood pressure, ICH may induce serious disability for the patients and continue to be a major socioeconomic problem. The evacuation of ICH using open craniotomy or computer tomography (CT)-guided stereotaxy may improve the survival rate of these patients but failed to prove efficacy in improving patients' functional outcome despite numerous efforts. Endoscopy-guided evacuation of ICH provides a less invasive and quicker surgical decompression, which may potentially improve the functional outcome for patients. In previous studies, endoscope-guided evacuation of ICH is often referred to as that an endoscope only provides an illuminating system while the operating channel is independent from the endoscope (endoscopy-controlled microneurosurgery or endoscopy-assisted microneurosurgery). In recent years, authors have been committed to explore the procedure of intra-endoscopy-guided evacuation of ICH, which means that the illuminating channel, the irrigation-aspiration channel and the working channel are all located in the endoscope. This kind of procedure can be called as real endoscopic neurosurgery (EN), which may potentially decrease the operative concomitant injuries at the most extent. However, the inherent drawbacks of intra-endoscopic procedures, including the limited visualization of the surgical field and the difficult maintenance of patency of the aspiration wand, can offset the advantages in some instances. The authors exclusively invented a special endoscopic transparent sheath for guiding hematoma puncture and an agitation-aspiration system (AAS) for keeping patency of the aspiration wand. Detailed procedures of their application will be implemented and verified in a series of patients with intracerebral hemorrhage. Meanwhile, the mortality rate, complications and other outcome parameters between this procedure and CT-guided procedures will be compared.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary basal ganglion region intracerebral hemorrhage
• older than 18 years
• admitted within 6 h after onset of ICH

Exclusion criteria

• other type of ICH than acute primary intracerebral hemorrhage
• patients who need neurosurgery
• life expectancy less than 3 months due to comorbid disorders
• confirmed malignant disease (cancer)
• confirmed acute myocardial infarction
• hepatitis and/liver cirrhosis
• renal failure
• infectious disease (HIV, endocarditis etc.)
• current or previous hematologic disease
• women of childbearing age if pregnant
• participation in another study within the preceding 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Intra-endoscopy

Experimental group

Description:

This intervention arm will receive intra-endoscopic evacuation surgery for ICH.

Treatment:

Procedure: Intra-endoscopic surgery

Stereotactic Aspiration

Placebo Comparator group

Description:

This arm will receive stereotactic aspiration surgery for ICH evacuation.

Treatment:

Procedure: Placebo:stereotactic aspiration surgery