Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.
Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Neurosurgery. 2020 Aug 1;87(2):394-402. doi: 10.1093/neuros/nyz527.
Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain.
To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy.
We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale.
We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.
癌症疼痛是晚期癌症患者最常见的症状之一，通常对最大程度的医学治疗有抗药性。需要进行对照临床试验，以提供确凿的证据支持使用诸如脊髓切开术等消融程序来治疗医学上难治性癌症疼痛的患者。
使用对照临床试验研究设计评估脊髓切开术治疗单侧晚期癌症疼痛患者的疗效。次要目标是定义脊髓切开术治疗医学上难治性癌症疼痛患者的体验，并确定磁共振成像作为成功脊髓切开术的非侵入性生物标志物的效用。
我们将在难治性癌症疼痛患者中进行一项单机构、双盲、假对照的脊髓切开术临床试验。脊髓切开术组的患者将接受经皮 CT 引导的 C1-C2 脊髓切开术，而对照组的患者将接受类似的手术，但针不会穿透硬脊膜囊。主要终点将是疼痛强度的降低，用埃德蒙顿症状评估量表测量。
我们预计随机分配到脊髓切开术的患者疼痛强度的降低将明显大于随机分配到对照组手术干预的患者。
这项比较脊髓切开术与对照干预的随机临床试验将提供必要的证据水平，以确定脊髓切开术是否应成为晚期癌症疼痛患者的标准治疗干预措施。
