A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Extent of resection
研究概览
简要总结
Spinal cord gliomas are the most common type of primary intramedullary malignant tumors, with a low incidence and a peak onset age of approximately 35 years. They are slightly more prevalent in males than females. Clinical manifestations vary depending on tumor characteristics and location, typically presenting with axial pain and displaying a tendency for unilateral, infiltrative growth. Prognosis is generally poor, and effective treatment options are limited aside from surgical resection. Common surgical approaches for intramedullary tumor removal include the posterior median sulcus approach, the dorsolateral sulcus approach, and surface entry techniques.
Preliminary clinical observations suggest that the dorsolateral sulcus approach may offer superior preservation of neurological function and quality of life. However, due to limited research evaluating the safety and efficacy of different surgical routes, the traditional posterior median sulcus approach remains widely used.
This single-center, registry-based cohort study aims to compare the outcomes of spinal cord glioma resection via the dorsolateral sulcus approach versus the posterior median sulcus approach. Patients with laterally located tumors undergoing surgical treatment, classified according to the 2021 WHO criteria, will be included. Neurological function scores and quality-of-life assessments will be used to evaluate prognosis and survival, in order to determine the optimal surgical approach for spinal cord glioma resection.
详细描述
Spinal cord gliomas are rare primary intramedullary tumors characterized by lateralized infiltrative growth and limited treatment options beyond surgical resection. Due to the anatomical complexity and functional sensitivity of the spinal cord, the choice of surgical approach significantly impacts postoperative neurological outcomes.
The traditional posterior median sulcus (PMS) approach provides direct midline access for tumor removal but carries a considerable risk of damage to central neural tracts. The dorsolateral sulcus (DLS) approach offers an alternative route for laterally located tumors, potentially sparing critical midline structures and improving functional outcomes.
This single-center, registry-based cohort study aims to evaluate and compare the clinical outcomes of spinal cord glioma resections performed via the DLS and PMS approaches. Patients will be enrolled based on eligibility criteria including lateralized tumor growth confirmed by imaging and histopathology, in accordance with the 2021 WHO classification of CNS tumors.
Primary and secondary outcomes will be assessed using validated clinical scales, including:
Visual Analog Scale (VAS) for pain assessment McCormick Functional Grading Scale Japanese Orthopaedic Association (JOA) Score for spinal cord function SF-36 Health Survey for quality of life evaluation Functional assessment of posterior column integrity Outcome assessments will be performed at five scheduled time points: preoperatively, and postoperatively at 1 month, 3 months, 6 months, and at the last follow-up visit. The study will evaluate neurological recovery, extent of resection, tumor recurrence, postoperative complications, and overall survival. This research aims to identify the optimal surgical approach that maximizes tumor resection while preserving neurological function in patients with spinal cord gliomas.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 3 and 75 years
- •Undergoing surgical resection of spinal cord tumor
- •Histopathological diagnosis of spinal cord glioma based on routine pathological examination
- •Availability of complete clinical data and willingness to participate in follow-up
- •Informed consent obtained from the patient and/or legal guardians or immediate family members
排除标准
- •Age under 3 years or over 75 years
- •Receipt of radiotherapy, chemotherapy, or anti-tumor biological therapy within 1 month prior to enrollment
- •Receipt of immunotherapy within 3 months prior to enrollment
- •Participation in other clinical trials within 3 months prior to enrollment
- •History of severe allergic reactions or known allergy-prone constitution
- •Pregnant or breastfeeding women, or individuals of childbearing potential not using adequate contraception
- •Presence of other severe medical conditions or uncontrolled infections
- •History of drug abuse, substance misuse, chronic alcoholism, or HIV infection
- •Uncontrolled epileptic seizures or psychiatric disorders resulting in loss of self-control
结局指标
主要结局
Extent of resection
时间窗: Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery
The extent of tumor resection was evaluated by comparing the preoperative and postoperative magnetic resonance images, and the criterion for judgment was that the tumor volume decreased by more than 50%.
Number of Participants with Preserved Dorsal Column Function (Assessed by clinical neurological examination and intraoperative electrophysiological monitoring )
时间窗: Preoperative, 1 month, 6 months
Dorsal column function will be assessed through standardized clinical neurological examination, including evaluation of proprioception (joint position sense), vibration sense, and gait. Dysfunction is defined as the presence of generalized numbness or painful dysesthesias below the surgical level, accompanied by proprioceptive loss and/or gait disturbance. \* This definition is based on previously published clinical criteria for dorsal column dysfunction in patients with intramedullary spinal cord tumors, as described by Manzano et al.
Pain Level (VAS Score)
时间窗: Preoperative, 1 month postoperative, 6 months postoperative, and 12 months postoperative
Assessment of pain severity using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 100 (worst possible pain).
Neurological Functional Status (McCormick Grade)
时间窗: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Evaluation of neurological status using the McCormick Functional Grading Scale to compare surgical approaches. The scale ranges from Grade I (normal gait and function) to Grade IV (severe disability or paraplegia).
次要结局
- SF-36 quality of life metrics(6 months and 12 months postoperative)
- Progression-Free Survival (PFS)(From date of surgery until tumor progression or death, assessed up to 24 months)
- Overall Survival (OS)(From date of surgery to death from any cause, assessed up to 36 months)