Schneider Daniel, Anschuetz Lukas, Mueller Fabian, Hermann Jan, O'Toole Bom Braga Gabriela, Wagner Franca, Weder Stefan, Mantokoudis Georgios, Weber Stefan, Caversaccio Marco
ARTORG Center for Biomedical Engineering, University of Bern, Bern, Switzerland.
Department of Otorhinolaryngology, Head & Neck Surgery, Inselspital, University Hospital Bern, Bern, Switzerland.
Front Surg. 2021 Oct 7;8:742112. doi: 10.3389/fsurg.2021.742112. eCollection 2021.
The use of freehand stereotactic image-guidance with a target registration error (TRE) of μ + 3σ < 0.5 mm for navigating surgical instruments during neurotologic surgery is safe and useful. Neurotologic microsurgery requires work at the limits of human visual and tactile capabilities. Anatomy localization comes at the expense of invasiveness caused by exposing structures and using them as orientation landmarks. In the absence of more-precise and less-invasive anatomy localization alternatives, surgery poses considerable risks of iatrogenic injury and sub-optimal treatment. There exists an unmet clinical need for an accurate, precise, and minimally-invasive means for anatomy localization and instrument navigation during neurotologic surgery. Freehand stereotactic image-guidance constitutes a solution to this. While the technology is routinely used in medical fields such as neurosurgery and rhinology, to date, it is not used for neurotologic surgery due to insufficient accuracy of clinically available systems. A freehand stereotactic image-guidance system tailored to the needs of neurotologic surgery-most importantly sub-half-millimeter accuracy-was developed. Its TRE was assessed preclinically using a task-specific phantom. A pilot clinical trial targeting N = 20 study participants was conducted (ClinicalTrials.gov ID: NCT03852329) to validate the accuracy and usefulness of the developed system. Clinically, objective assessment of the TRE is impossible because establishing a sufficiently accurate ground-truth is impossible. A method was used to validate accuracy and usefulness based on intersubjectivity assessment of surgeon ratings of corresponding image-pairs from the microscope/endoscope and the image-guidance system. During the preclinical accuracy assessment the TRE was measured as 0.120 ± 0.05 mm (max: 0.27 mm, μ + 3σ = 0.27 mm, = 310). Due to the COVID-19 pandemic, the study was terminated early after = 3 participants. During an endoscopic cholesteatoma removal, a microscopic facial nerve schwannoma removal, and a microscopic revision cochlear implantation, = 75 accuracy and usefulness ratings were collected from five surgeons each grading 15 image-pairs. On a scale from 1 (worst rating) to 5 (best rating), the median (interquartile range) accuracy and usefulness ratings were assessed as 5 (4-5) and 4 (4-5) respectively. Navigating surgery in the tympanomastoid compartment and potentially in the lateral skull base with sufficiently accurate freehand stereotactic image-guidance (μ + 3σ < 0.5 mm) is feasible, safe, and useful. www.ClinicalTrials.gov, identifier: NCT03852329.
在神经耳科手术中,使用徒手立体定向图像引导技术,目标配准误差(TRE)为μ + 3σ < 0.5毫米来引导手术器械是安全且有用的。神经耳科显微手术需要在人类视觉和触觉能力的极限下进行操作。解剖定位是以暴露结构并将其用作定向标志所带来的侵袭性为代价的。在缺乏更精确且侵入性更小的解剖定位替代方法的情况下,手术存在相当大的医源性损伤风险和治疗效果欠佳的问题。临床上迫切需要一种准确、精确且微创的方法来进行神经耳科手术中的解剖定位和器械导航。徒手立体定向图像引导技术为这一需求提供了解决方案。虽然该技术在神经外科和鼻科等医学领域已常规使用,但由于临床可用系统的准确性不足,迄今为止尚未用于神经耳科手术。我们开发了一种针对神经耳科手术需求量身定制的徒手立体定向图像引导系统,最重要的是其精度达到亚半毫米。我们使用特定任务的体模对其TRE进行了临床前评估。针对20名研究参与者开展了一项试点临床试验(ClinicalTrials.gov标识符:NCT03852329),以验证所开发系统的准确性和实用性。在临床上,由于无法建立足够准确的真实情况,所以无法对TRE进行客观评估。我们采用了一种基于对来自显微镜/内窥镜和图像引导系统的相应图像对的外科医生评级进行主体间评估的方法来验证准确性和实用性。在临床前准确性评估中,测得TRE为0.120 ± 0.05毫米(最大值:0.27毫米,μ + 3σ = 0.27毫米,样本量 = 310)。由于新冠疫情,在纳入3名参与者后该研究提前终止。在一次内窥镜下胆脂瘤切除、一次显微镜下面神经鞘瘤切除以及一次显微镜下人工耳蜗植入翻修手术中,从5名外科医生那里收集了75个准确性和实用性评级,每位医生对15对图像进行评分。在从1(最差评分)到5(最佳评分)的量表上,准确性和实用性评级的中位数(四分位间距)分别评估为5(4 - 5)和4(4 - 5)。使用足够精确的徒手立体定向图像引导技术(μ + 3σ < 0.5毫米)在鼓室乳突腔以及可能在侧颅底进行手术导航是可行、安全且有用的。www.ClinicalTrials.gov,标识符:NCT03852329。