Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases

Обзор

Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous. This prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care. The investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care. Preoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel/bladder function, treatment complications, and survival. The primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery. This study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates. Through this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.

Первичные конечные точки

• Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery [Срок оценки: Baseline (preoperative) to 1 month postoperatively]

Вторичные конечные точки (12)

• Sex of Participant [Срок оценки: preoperative]
• Age of Participant [Срок оценки: preoperative]
• ECOG Performance Status [Срок оценки: preoperative]
• Time from Primary Cancer Diagnosis to Surgery [Срок оценки: preoperative]
• Time from Spinal Metastasis Diagnosis to Surgery [Срок оценки: preoperative]
• Histological Type of Primary Tumor [Срок оценки: preoperative]
• History of Preoperative Oncologic Treatment and Surgery [Срок оценки: preoperative]
• Anatomical Location and Extent of Spinal Tumor Involvement [Срок оценки: preoperative]
• Pain Intensity Score [Срок оценки: Baseline and postoperative follow-ups (1, 3, 6 months)]
• : Quality of Life Assessment Using QLQ-C30 [Срок оценки: Baseline, 1, 3, 6 and 12 months postoperatively]
• Epidural Spinal Cord Compression (ESCC) Grade and Neurological Responsibility Level [Срок оценки: preoperative]
• Spinal Instability Neoplastic Score [Срок оценки: preoperative]

Критерии участия

Критерии включения

• Age between 18 and 80 years at the time of enrollment.
• Clinical diagnosis of spinal metastases with resulting motor paralysis.
• Scheduled for surgical decompression and/or spinal stabilization.
• Medically fit to undergo surgery as determined by preoperative evaluation.
• Ability to understand the study and provide written informed consent.
• Willingness and ability to complete neurological and functional follow-up assessments.

Критерии исключения

• Medically unfit for surgery due to unstable comorbidities or poor general condition.
• Pregnant or breastfeeding at the time of enrollment.
• Significant cognitive impairment or psychiatric illness that interferes with informed consent or study participation.
• Expected difficulty in completing follow-up assessments or anticipated loss to follow-up.
• Missing critical baseline or follow-up data relevant to study endpoints.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kim CH, Chung CK, Jahng TA, Kim HJ. Resumption of ambulatory status after surgery for nonambulatory patients with epidural spinal metastasis. Spine J. 2011 Nov;11(11):1015-23. doi: 10.1016/j.spinee.2011.09.007. Epub 2011 Oct 14. PMID 22000724
• Kato S, Hozumi T, Takeshita K, Kondo T, Goto T, Yamakawa K. Neurological recovery after posterior decompression surgery for anterior dural compression in paralytic spinal metastasis. Arch Orthop Trauma Surg. 2012 Jun;132(6):765-71. doi: 10.1007/s00402-012-1475-x. Epub 2012 Feb 14. PMID 22327407
• Ohashi M, Hirano T, Watanabe K, Katsumi K, Shoji H, Sano A, Tashi H, Takahashi I, Wakasugi M, Shibuya Y, Endo N. Preoperative prediction for regaining ambulatory ability in paretic non-ambulatory patients with metastatic spinal cord compression. Spinal Cord. 2017 May;55(5):447-453. doi: 10.1038/sc.2016.145. Epub 2016 Oct 18. PMID 27752060
• Li S, Zhong N, Xu W, Yang X, Wei H, Xiao J. The impact of surgical timing on neurological outcomes and survival in patients with complete paralysis caused by spinal tumours: evaluation of surgery on patients with complete paralysis due to neoplastic epidural spinal cord compression. Bone Joint J. 2019 Jul;101-B(7):872-879. doi: 10.1302/0301-620X.101B7.BJJ-2018-1173.R1. PMID 31256678
• Younsi A, Riemann L, Ishak B, Scherer M, Unterberg AW, Zweckberger K. Feasibility of salvage decompressive surgery for pending paralysis due to metastatic spinal cord compression. Clin Neurol Neurosurg. 2021 Mar;202:106509. doi: 10.1016/j.clineuro.2021.106509. Epub 2021 Jan 22. PMID 33540174

Идентификаторы

NCT: NCT07527728 · 2025SL079

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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