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

Primary Purpose

Intracerebral Hemorrhage, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intra-endoscopic surgery
Placebo:stereotactic aspiration surgery
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Endoscopy, Intracerebral hemorrhage, surgery, stereotactic aspiration, Key-hole approach, Intracerebral hemorrhage surgical treatment, Transparent endoscopic sheath, Agitation-aspiration device

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nanfang Hospital of Southern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intra-endoscopy

Stereotactic Aspiration

Arm Description

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

This arm will receive stereotactic aspiration surgery for ICH evacuation.

Outcomes

Primary Outcome Measures

Mortality rate
all-cause motality rate within 90 days after the surgery

Secondary Outcome Measures

operative time
the period from skin incision to wound suture
days of ICU stay
the period between the end of the surgery to leaving the ICU
remnant blood in the hematoma after surgery
this parameter will be monitored by CT scan immediately after the surgery
Glasgow coma score
the GCS will be evaluated by a senior doctor 28 days after the surgery
Glasgow outcome score
the GCS will be evaluated by a senior doctor 28 days after the surgery
In-hospital cost
all medical cost during the in-hospital period
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
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

Full Information

First Posted
July 22, 2015
Last Updated
August 2, 2015
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02515903
Brief Title
Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage
Acronym
EndoSurofICH
Official Title
Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Surgery
Keywords
Endoscopy, Intracerebral hemorrhage, surgery, stereotactic aspiration, Key-hole approach, Intracerebral hemorrhage surgical treatment, Transparent endoscopic sheath, Agitation-aspiration device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-endoscopy
Arm Type
Experimental
Arm Description
This intervention arm will receive intra-endoscopic evacuation surgery for ICH.
Arm Title
Stereotactic Aspiration
Arm Type
Placebo Comparator
Arm Description
This arm will receive stereotactic aspiration surgery for ICH evacuation.
Intervention Type
Procedure
Intervention Name(s)
Intra-endoscopic surgery
Intervention Description
Intra-endoscopic surgery for evacuation of ICH
Intervention Type
Procedure
Intervention Name(s)
Placebo:stereotactic aspiration surgery
Intervention Description
Placebo:stereotactic aspiration surgery for evacuation of ICH
Primary Outcome Measure Information:
Title
Mortality rate
Description
all-cause motality rate within 90 days after the surgery
Time Frame
90-day
Secondary Outcome Measure Information:
Title
operative time
Description
the period from skin incision to wound suture
Time Frame
24 h
Title
days of ICU stay
Description
the period between the end of the surgery to leaving the ICU
Time Frame
14 day
Title
remnant blood in the hematoma after surgery
Description
this parameter will be monitored by CT scan immediately after the surgery
Time Frame
12 hour
Title
Glasgow coma score
Description
the GCS will be evaluated by a senior doctor 28 days after the surgery
Time Frame
28 day
Title
Glasgow outcome score
Description
the GCS will be evaluated by a senior doctor 28 days after the surgery
Time Frame
90-day
Title
In-hospital cost
Description
all medical cost during the in-hospital period
Time Frame
28 day
Title
rehemorrhage rate
Description
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
Time Frame
3 day
Title
intracranial infection
Description
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
Time Frame
14 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Du, MD
Phone
86-13823699011
Email
ftipa@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-ping Peng, MD
Phone
86-15914141979
Email
83936462@qq.com
Facility Information:
Facility Name
Nanfang Hospital of Southern University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song-tao Qi, MD
Phone
86-15914141979
Email
szph0077@163.com
First Name & Middle Initial & Last Name & Degree
Bo Du, MD
Phone
86-13823699011
Email
dubo19810218@163.com
First Name & Middle Initial & Last Name & Degree
Jin Wang, MD
First Name & Middle Initial & Last Name & Degree
Xian-liang Zhong, MD
First Name & Middle Initial & Last Name & Degree
Jian Liang, MD
First Name & Middle Initial & Last Name & Degree
Lian-gong Long, MD
First Name & Middle Initial & Last Name & Degree
Yuan-bo Zhong, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32010057
Citation
Du B, Xu J, Hu J, Zhong X, Liang J, Lei P, Wang H, Li W, Peng Y, Shan A, Zhang Y. A Clinical Study of the Intra-Neuroendoscopic Technique for the Treatment of Subacute-Chronic and Chronic Septal Subdural Hematoma. Front Neurol. 2020 Jan 17;10:1408. doi: 10.3389/fneur.2019.01408. eCollection 2019.
Results Reference
derived
PubMed Identifier
31080494
Citation
Zhang Y, Shan AJ, Peng YP, Lei P, Xu J, Zhong X, Du B. The intra-neuroendoscopic technique (INET): a modified minimally invasive technique for evacuation of brain parenchyma hematomas. World J Emerg Surg. 2019 May 6;14:21. doi: 10.1186/s13017-019-0239-0. eCollection 2019.
Results Reference
derived
PubMed Identifier
29926826
Citation
Du B, Shan AJ, Zhang YJ, Wang J, Peng KW, Zhong XL, Peng YP. The intra-neuroendoscopic technique: A new method for rapid removal of acute severe intraventricular hematoma. Neural Regen Res. 2018 Jun;13(6):999-1006. doi: 10.4103/1673-5374.233442.
Results Reference
derived

Learn more about this trial

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

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