Department of Neurosurgery, Sanbo Brain Hospital, Capital Medical University, Haidian District, No. 50, Yikesong Road, Beijing, 100093, China.
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, China.
Trials. 2023 Jun 9;24(1):387. doi: 10.1186/s13063-023-07334-9.
This protocol describes the design of a multicenter randomized controlled trial of robot-assisted stereotactic lesioning versus epileptogenic foci resection. Typical causes of focal epilepsy include hippocampal sclerosis and focal cortical dysplasia. These patients usually present with drug resistance and require surgical treatment. Although epileptogenic foci resection is still the most commonly used treatment for such focal epilepsy, there is increasing evidence that epileptogenic focus resection may lead to neurological impairment. The treatment of epilepsy with a robot-assisted stereotactic lesioning mainly includes two new minimally invasive surgical methods: radiofrequency thermocoagulation (RF-TC) and laser interstitial thermal therapy (LITT). Seizure-free is less likely to be achieved by these two procedures, but neurologic preservation is better. In this study, we aimed to compare the safety and efficacy of RF-TC, LITT, and epileptogenic foci resection for focal drug-resistant epilepsy.
This is a multicenter, three-arm, randomized controlled clinical trial. The study will include patients older than 3 years of age with epilepsy who have had medically refractory seizures for at least 2 years and are eligible for surgical treatment with an epileptogenic focus as determined by multidisciplinary evaluation prior to randomization. The primary outcome measure is seizure outcome (quantified by seizure remission rate) at 3-month, 6-month, and 1-year follow-up after treatment. Postoperative neurologic impairment, spectrum distribution change of video electroencephalogram, quality of life, and medical costs will also be assessed as secondary outcomes.
Chinese Clinical Trials Registry ChiCTR2200060974. Registered on June 14, 2022. The status of the trial is recruiting, and the estimated study completion date is December 31, 2024.
本方案描述了一项多中心随机对照试验的设计，该试验比较了机器人辅助立体定向损毁术与致痫灶切除术治疗局灶性癫痫的效果。局灶性癫痫的常见病因包括海马硬化和局灶性皮质发育不良。这些患者通常存在药物抵抗，需要手术治疗。虽然致痫灶切除术仍然是治疗此类局灶性癫痫最常用的方法，但越来越多的证据表明，致痫灶切除术可能导致神经功能损伤。机器人辅助立体定向损毁术治疗癫痫主要包括两种新的微创外科方法：射频热凝（RF-TC）和激光间质热疗（LITT）。这两种方法实现无癫痫发作的可能性较低，但神经保护效果较好。本研究旨在比较 RF-TC、LITT 和致痫灶切除术治疗药物难治性局灶性癫痫的安全性和疗效。
这是一项多中心、三臂、随机对照临床试验。研究将纳入年龄大于 3 岁、经多学科评估确定存在致痫灶且药物难治性癫痫发作至少 2 年、适合手术治疗的患者。在随机分组前，患者均接受了致痫灶切除术。主要结局指标为治疗后 3 个月、6 个月和 1 年随访时的癫痫发作结局（以癫痫发作缓解率衡量）。术后神经功能损伤、视频脑电图频谱分布变化、生活质量和医疗费用也将作为次要结局进行评估。
中国临床试验注册中心 ChiCTR2200060974。注册于 2022 年 6 月 14 日。试验的状态为招募中，预计研究完成日期为 2024 年 12 月 31 日。
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