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Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209804
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Shuo Wang, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date March 13, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Instant residual rate of AVMs [ Time Frame: up to 1 week after operation ]
    The instant post-operative residual rate of AVMs
  • 3 months' residual rate of AVMs [ Time Frame: the date of 3rd month after operation, ±1 week ]
    3 months' residual rate after AVM operation
  • 6 months' residual rate of AVMs [ Time Frame: the date of the 6th month after operation, ±1 week ]
    6 months' residual rate after AVM operation
  • 1 year's residual rate of AVMs [ Time Frame: the date of the 12th month after operation, ±1 week ]
    1 year's residual rate after AVM operation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Morbidity rate of post-operative complications [ Time Frame: 7 days after operation ]
    Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications
  • Post-operative mortality rate [ Time Frame: 48 hours after operation ]
    operation related mortality
  • Morbidity rate of neural functional deterioration-48 hours after operation [ Time Frame: the assessing time points is 48 hours after operation ]
    The score of modified Rankin Scale increases ≥2
  • Morbidity rate of neural functional deterioration-1 week after operation [ Time Frame: 1 week after operation ]
    The score of modified Rankin Scale increases ≥2
  • Morbidity rate of neural functional deterioration-3 months after operation [ Time Frame: the 3rd month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2
  • Morbidity rate of neural functional deterioration-6 months after operation [ Time Frame: the 6th month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2
  • Morbidity rate of neural functional deterioration-12 months after operation [ Time Frame: the 12th month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Official Title  ICMJE Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Brief Summary To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
Detailed Description

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Traditional therapy group:traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group.

Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Arteriovenous Malformations
Intervention  ICMJE Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
  • endovascular interventional embolisation
  • endovascular interventional balloon occlusion
  • microsurgical resection
Study Arms  ICMJE
  • Traditional neurosurgical techniques
    Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
    Intervention: Procedure: hybrid operating techniques
  • Experimental: Hybrid operating techniques
    A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
    Intervention: Procedure: hybrid operating techniques
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2020)
519
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
302
Actual Study Completion Date  ICMJE January 16, 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • newly ruptured AVM with stable hematoma, selective operation is practical;
  • with rupture history;
  • recurrent epilepsy, failed in AED management;
  • giant AVM with deterioration of neurological functions;
  • 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion Criteria:

  • >70 in age, with low rupture risk;
  • newly ruptured AVM with unstable hematoma, engaged in emergency operation;
  • ≥5 grade in Spetzler-Martin grading system;
  • AVM located in hypothalamus, brainstem, cerebellopontine angle;
  • cannot tolerant the operation;
  • patient or relative refuses to participate the trail.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209804
Other Study ID Numbers  ICMJE BJTTH-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shuo Wang, Beijing Tiantan Hospital
Study Sponsor  ICMJE Ministry of Science and Technology of the People´s Republic of China
Collaborators  ICMJE Beijing Municipal Science & Technology Commission
Investigators  ICMJE Not Provided
PRS Account Ministry of Science and Technology of the People´s Republic of China
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP