Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with Paralysis Due to Spinal Metastases.
Patients with paralysis due to spinal metastases who undergo surgery will be included in this cohort and followed over time to assess clinical outcomes.
结局指标
主要结局
Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery
时间窗: Baseline (preoperative) to 1 month postoperatively
The primary outcome is the distribution and change in ASIA Impairment Grades at 1 month after surgery compared to baseline. The ASIA (American Spinal Injury Association) Impairment Scale categorizes spinal cord injury severity from Grade A (complete injury) to Grade E (normal motor and sensory function). An improvement is defined as a shift to a higher ASIA grade (e.g., from C to D or D to E). The proportion of patients showing at least 1-grade improvement will be calculated to reflect early neurological recovery following surgical decompression and stabilization for metastatic spinal cord compression.
次要结局
- : Quality of Life Assessment Using QLQ-C30(Baseline, 1, 3, 6 and 12 months postoperatively)
- Sex of Participant(preoperative)
- Age of Participant(preoperative)
- ECOG Performance Status(preoperative)
- Time from Primary Cancer Diagnosis to Surgery(preoperative)
- Time from Spinal Metastasis Diagnosis to Surgery(preoperative)
- Histological Type of Primary Tumor(preoperative)
- History of Preoperative Oncologic Treatment and Surgery(preoperative)
- Anatomical Location and Extent of Spinal Tumor Involvement(preoperative)
- Pain Intensity Score(Baseline and postoperative follow-ups (1, 3, 6 months))
- Epidural Spinal Cord Compression (ESCC) Grade and Neurological Responsibility Level(preoperative)
- Spinal Instability Neoplastic Score(preoperative)
- PET-CT Assessment: Solid Organ Metastases and Spinal Tumor Burden(preoperative)
- Preoperative ASIA Impairment Grade(preoperative)
- Time from Incomplete Paralysis to Surgery(preoperative)
- Modified Ashworth Scale for Spasticity(preoperative,3 month, 6 month,12 month)
- Duration of Surgery(Intraoperative)
- Surgical Location(Intraoperative)
- Intraoperative Blood Loss Volume(Intraoperative)
- Use of Instrumented Internal Fixation(Intraoperative)
- Tumor Resection Method(Intraoperative)
- Postoperative Pathology Results(Postoperative(within 20 days))
