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

Surgery Clinical Trial

— EndoSurofICH  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02515903
• Other study ID #: NFYY-NSD-001
• Status: Unknown status
• Phase: N/A
• First received: July 22, 2015
• Last updated: August 2, 2015
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: Nanfang Hospital of Southern Medical University
• Contact: Bo Du, MD
• Phone: 86-13823699011
• Email: ftipa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Surgery

Intervention

Procedure:
• Intra-endoscopic surgery
Intra-endoscopic surgery for evacuation of ICH
• Placebo:stereotactic aspiration surgery
Placebo:stereotactic aspiration surgery for evacuation of ICH

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	all-cause motality rate within 90 days after the surgery	90-day
Secondary	operative time	the period from skin incision to wound suture	24 h
Secondary	days of ICU stay	the period between the end of the surgery to leaving the ICU	14 day
Secondary	remnant blood in the hematoma after surgery	this parameter will be monitored by CT scan immediately after the surgery	12 hour
Secondary	Glasgow coma score	the GCS will be evaluated by a senior doctor 28 days after the surgery	28 day
Secondary	Glasgow outcome score	the GCS will be evaluated by a senior doctor 28 days after the surgery	90-day
Secondary	In-hospital cost	all medical cost during the in-hospital period	28 day
Secondary	rehemorrhage rate	Rehemorrhage almost occurs within 3 days after the surger. So cranial CT scan will be performed routinely 3 days later after surgery to evaluate the rehemorrhage rate	3 day
Secondary	intracranial infection	If the patient underwent a period of fever, cerebral fluid will be withdrawn by means of lumbar puncture and tested to verify whether the intracranial infection occurs	14 day