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Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial

INTRODUCTION: Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI...

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Autores principales: Zhao, Bing, Cao, Yong, Zhao, Yuanli, Wu, Jun, Wang, Shuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208052/
https://www.ncbi.nlm.nih.gov/pubmed/25341453
http://dx.doi.org/10.1136/bmjopen-2014-006618
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author Zhao, Bing
Cao, Yong
Zhao, Yuanli
Wu, Jun
Wang, Shuo
author_facet Zhao, Bing
Cao, Yong
Zhao, Yuanli
Wu, Jun
Wang, Shuo
author_sort Zhao, Bing
collection PubMed
description INTRODUCTION: Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial. METHODS AND ANALYSIS: The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery. ETHICS AND DISSEMINATION: The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01758211.
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spelling pubmed-42080522014-10-27 Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial Zhao, Bing Cao, Yong Zhao, Yuanli Wu, Jun Wang, Shuo BMJ Open Surgery INTRODUCTION: Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial. METHODS AND ANALYSIS: The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery. ETHICS AND DISSEMINATION: The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01758211. BMJ Publishing Group 2014-10-24 /pmc/articles/PMC4208052/ /pubmed/25341453 http://dx.doi.org/10.1136/bmjopen-2014-006618 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Surgery
Zhao, Bing
Cao, Yong
Zhao, Yuanli
Wu, Jun
Wang, Shuo
Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title_full Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title_fullStr Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title_full_unstemmed Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title_short Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
title_sort functional mri-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208052/
https://www.ncbi.nlm.nih.gov/pubmed/25341453
http://dx.doi.org/10.1136/bmjopen-2014-006618
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