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低场术中磁共振引导无框架立体定向脑肿瘤活检的安全性和有效性:一项前瞻性随机试验的设计和中期分析。

The safety and effectiveness of low field intraoperative MRI guidance in frameless stereotactic biopsies of brain tumours-design and interim analysis of a prospective randomized trial.

机构信息

Department of Neurosurgery, Wroclaw Medical University, Ul. Borowska 213, 50-556, Wrocław, Poland,

出版信息

Neurosurg Rev. 2014 Jan;37(1):127-37. doi: 10.1007/s10143-013-0486-6. Epub 2013 Jul 3.

Abstract

The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative magnetic resonance imaging (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial. A pilot group of 42 brain tumour patients was prospectively randomized into a low-field iMRI group and a control group that underwent a frameless STx biopsy. The primary endpoints of the analysis were postoperative complication rate and diagnostic yield, and the secondary endpoints were length of hospital stay and duration of operation. The iMRI group (21 patients) and the control group (21 patients) did not differ significantly according to demographic and epidemiological data. No major postoperative complications were noted in either group. In addition, no significant differences in the diagnostic yield (p = 1.00) and length of hospital stay (p = 0.16) were observed. The mean total OR time was 111 ± 24 min in iMRI and 78 ± 29 min in the control group (p = 0.0001). Usage of iMRI may prolong the time of the procedure but seems to be comparable in safety and effectiveness to the standard frameless STx biopsy.

摘要

本研究旨在评估低场术中磁共振成像(iMRI)引导立体定向脑肿瘤活检(STx 活检)的安全性和有效性,并与无框架经典模拟方法进行前瞻性随机对照试验比较。42 例脑肿瘤患者前瞻性随机分为低场 iMRI 组和无框架 STx 活检对照组。分析的主要终点是术后并发症发生率和诊断率,次要终点是住院时间和手术时间。iMRI 组(21 例)和对照组(21 例)在人口统计学和流行病学数据方面无显著差异。两组均未出现重大术后并发症。此外,诊断率(p=1.00)和住院时间(p=0.16)无显著差异。iMRI 组的总手术时间为 111±24 分钟,对照组为 78±29 分钟(p=0.0001)。使用 iMRI 可能会延长手术时间,但在安全性和有效性方面似乎与标准无框架 STx 活检相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5aac/3889652/81315293d4e3/10143_2013_486_Fig1_HTML.jpg

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