Intraoperative electrocorticography using high-frequency oscillations or spikes to tailor epilepsy surgery in the Netherlands (the HFO trial): a randomised, single-blind, adaptive non-inferiority trial

皮质电图 癫痫外科 癫痫 医学 随机对照试验 脑电图 麻醉 外科 精神科
作者
Willemiek Zweiphenning,Maryse A. van ’t Klooster,Nicole van Klink,Frans S.S. Leijten,Cyrille H. Ferrier,Tineke Gebbink,Geertjan Huiskamp,M.J.E. van Zandvoort,Monique M.J. van Schooneveld,M Bourez,Sophie Goemans,Sven Straumann,Peter C. van Rijen,Peter H. Gosselaar,Pieter van Eijsden,Willem M. Otte,Eric van Diessen,Kees P. J. Braun,Maeike Zijlmans,Eltje M. Bloemen-Carlier,Veronika Cibulková,Renee de Munnink,Sandra van der Salm,Martinus J.C. Eijkemans,Janine M. Ophorst-van Eck,Anouk Velders,Charlotte J.J. van Asch,Jack Zwemmer,Renate van Regteren-van Griethuysen,Henriette Smeding,Lydia van der Berg,Jeroen de Bresser,G.A.P. de Kort,Jan-Willem Dankbaar
出处
期刊:Lancet Neurology [Elsevier BV]
卷期号:21 (11): 982-993 被引量:60
标识
DOI:10.1016/s1474-4422(22)00311-8
摘要

Intraoperative electrocorticography is used to tailor epilepsy surgery by analysing interictal spikes or spike patterns that can delineate epileptogenic tissue. High-frequency oscillations (HFOs) on intraoperative electrocorticography have been proposed as a new biomarker of epileptogenic tissue, with higher specificity than spikes. We prospectively tested the non-inferiority of HFO-guided tailoring of epilepsy surgery to spike-guided tailoring on seizure freedom at 1 year.The HFO trial was a randomised, single-blind, adaptive non-inferiority trial at an epilepsy surgery centre (UMC Utrecht) in the Netherlands. We recruited children and adults (no age limits) who had been referred for intraoperative electrocorticography-tailored epilepsy surgery. Participants were randomly allocated (1:1) to either HFO-guided or spike-guided tailoring, using an online randomisation scheme with permuted blocks generated by an independent data manager, stratified by epilepsy type. Treatment allocation was masked to participants and clinicians who documented seizure outcome, but not to the study team or neurosurgeon. Ictiform spike patterns were always considered in surgical decision making. The primary endpoint was seizure outcome after 1 year (dichotomised as seizure freedom [defined as Engel 1A-B] vs seizure recurrence [Engel 1C-4]). We predefined a non-inferiority margin of 10% risk difference. Analysis was by intention to treat, with prespecified subgroup analyses by epilepsy type and for confounders. This completed trial is registered with the Dutch Trial Register, Toetsingonline ABR.NL44527.041.13, and ClinicalTrials.gov, NCT02207673.Between Oct 10, 2014, and Jan 31, 2020, 78 individuals were enrolled to the study and randomly assigned (39 to HFO-guided tailoring and 39 to spike-guided tailoring). There was no loss to follow-up. Seizure freedom at 1 year occurred in 26 (67%) of 39 participants in the HFO-guided group and 35 (90%) of 39 in the spike-guided group (risk difference -23·5%, 90% CI -39·1 to -7·9; for the 48 patients with temporal lobe epilepsy, the risk difference was -25·5%, -45·1 to -6·0, and for the 30 patients with extratemporal lobe epilepsy it was -20·3%, -46·0 to 5·4). Pathology associated with poor prognosis was identified as a confounding factor, with an adjusted risk difference of -7·9% (90% CI -20·7 to 4·9; adjusted risk difference -12·5%, -31·0 to 5·9, for temporal lobe epilepsy and 5·8%, -7·7 to 19·5, for extratemporal lobe epilepsy). We recorded eight serious adverse events (five in the HFO-guided group and three in the spike-guided group) requiring hospitalisation. No patients died.HFO-guided tailoring of epilepsy surgery was not non-inferior to spike-guided tailoring on intraoperative electrocorticography. After adjustment for confounders, HFOs show non-inferiority in extratemporal lobe epilepsy. This trial challenges the clinical value of HFOs as an epilepsy biomarker, especially in temporal lobe epilepsy. Further research is needed to establish whether HFO-guided intraoperative electrocorticography holds promise in extratemporal lobe epilepsy.UMCU Alexandre Suerman, EpilepsieNL, RMI Talent Fellowship, European Research Council, and MING Fund.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
香香关注了科研通微信公众号
2秒前
NightGlow完成签到,获得积分10
2秒前
3秒前
安静无招完成签到 ,获得积分10
4秒前
4秒前
NexusExplorer应助fengliurencai采纳,获得10
6秒前
NexusExplorer应助古月采纳,获得10
6秒前
星辰大海应助33采纳,获得10
8秒前
彭彭发布了新的文献求助10
10秒前
12秒前
老大蒂亚戈应助潇湘雪月采纳,获得10
13秒前
13秒前
15秒前
15秒前
kk完成签到,获得积分10
15秒前
16秒前
HOPE发布了新的文献求助10
16秒前
AAA完成签到,获得积分10
18秒前
Singularity应助讨厌科研采纳,获得10
18秒前
古月发布了新的文献求助10
19秒前
20秒前
33发布了新的文献求助10
20秒前
汉堡包应助于平川春野采纳,获得10
20秒前
星星发布了新的文献求助10
22秒前
23秒前
赘婿应助十九岁的时差采纳,获得10
23秒前
怠惰vs勤劳完成签到,获得积分10
24秒前
夏天应助青山采纳,获得100
25秒前
26秒前
乖猫要努力应助潇湘雪月采纳,获得10
27秒前
wdy111举报风之星求助涉嫌违规
27秒前
古月完成签到,获得积分10
28秒前
28秒前
29秒前
吴所谓发布了新的文献求助50
32秒前
英吉利25发布了新的文献求助10
33秒前
34秒前
酷波er应助南冥采纳,获得10
34秒前
李沐唅完成签到 ,获得积分10
38秒前
lv完成签到,获得积分10
38秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989390
求助须知:如何正确求助?哪些是违规求助? 3531487
关于积分的说明 11254109
捐赠科研通 3270153
什么是DOI,文献DOI怎么找? 1804887
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809174